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Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6

Image 0 of Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6Image 1 of Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6Image 2 of Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6

Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6

$234.00

UPC No.:356091019750 Mfg. Item No.:1975 Johnson & Johnson Surgifoam 8Cm X 12.5Cm X 2mm Absorbable Gelatin Sponges 6 Item No.:C2949162/B451542 Item Profile
Ndc 63713001975
Generic Name Gelatin Sponge Absorbable
Trade Name Surgifoam 102Cmsqx2mm
Additional Description
Form Spng
Size 6 Each
Unit of Measure Each
Unit of Sale Cn
Unit Dose
Schedule No. 0
Private Label 999
Multi-Source Y
Active Status Active
Generic Ind. Non Drug
Drug Class Rx
Vendor Name

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DESCRIPTION
The SURGIFOAM Absorbable Gelatin Sponge, U.S.P. is a sterile, water-insoluble, malleable, porcinegelatin absorbable sponge intended for hemostatic use by applying to a bleeding surface. The spongeis off-white and porous in appearance.

INTENDED USE/INDICATIONS
SURGIFOAM Sponge, used dry or saturated with sterile sodium chloride solution, is indicated for surgical procedures (except urologic and ophthalmic) for hemostasis, when control of capillary,venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. Although not necessary, SURGIFOAM sponge can be used with or without thrombin to achieve hemostasis.

CONTRAINDICATIONS
Do not use SURGIFOAM Sponge in closure of skin incisions because it may interfere with the healingof skin edges. This interference is due to mechanical interposition of gelatin and is not secondary tointrinsic interference with wound healing. Do not use SURGIFOAM Sponge in intravascular compart-ments because of the risk of embolization. Do not use SURGIFOAM Sponge in patients with knownallergies to porcine collagen.

WARNINGS
? SURGIFOAM Sponge is not intended as a substitute for meticulous surgical technique and the properapplication of ligatures or other conventional procedures for hemostasis.
? SURGIFOAM Sponge should not be used in the presence of infection. SURGIFOAM Sponge should be used with caution in contaminated areas of the body. If signs of infection or abscess developwhere SURGIFOAM Sponge has been positioned, reoperation may be necessary in order to removethe infected material and allow drainage.
? SURGIFOAM Sponge should not be used in instances of pumping arterial hemorrhage. It should not be used where blood or other fluids have pooled or in cases where the point of hemorrhage issubmerged. SURGIFOAM Sponge will not act as a tampon or plug in a bleeding site, nor will it closeoff an area of blood collecting behind a tampon.
? SURGIFOAM Sponge should be removed if possible once hemostasis has been achieved because ofthe possibility of dislodgment of the device or compression of other nearby anatomic structures.
? SURGIFOAM Sponge should be removed from the site of application when used in, around, or inproximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
? The safety and effectiveness of SURGIFOAM Sponge for use in ophthalmic and urological procedureshas not been established.
? SURGIFOAM Sponge should not be used for controlling post-partum bleeding or menorrhagia.
? The safety and effectiveness of SURGIFOAM Sponge has not been established in children and preg-nant women.

PRECAUTIONS
SURGIFOAM Sponge is supplied as a sterile product and cannot be resterilized. Unused openenvelopes of SURGIFOAM Sponge should be discarded.

When placed into cavities or closed tissue spaces, minimal preliminary compression isadvised and care should be exercised to avoid overpacking (the sponge expands uponabsorption of liquid). SURGIFOAM Sponge may swell to its original size on absorbing fluids creating the potential for nerve damage.

While packing a cavity for hemostasis is sometimes surgically indicated, SURGIFOAMSponge should not be used in this manner unless excess product not needed to maintainhemostasis is removed.

Only the minimum amount of SURGIFOAM Sponge needed to achieve hemostasis should be used. Once hemostasis is achieved any excess SURGIFOAM Sponge should be carefullyremoved.

SURGIFOAM Sponge should not be used in conjunction with autologous blood salvage circuits. It has been demonstrated that fragments of collagen based hemostatic agents may pass through 40μtransfusion filters of blood scavenging systems.

SURGIFOAM Sponge should not be used in conjunction with methylmethacrylate adhesives.Microfibrillar collagen has been reported to reduce the strength of methylmethacrylate adhe-sives used to attach prosthetic devices to bone surfaces.

SURGIFOAM Sponge should not be used for the primary treatment of coagulation disorders.

Although the safety and effectiveness of the combined use of SURGIFOAM Sponge withother agents such as topical thrombin, antibiotic solution or antibiotic powder has not beenevaluated in controlled clinical trials, if in the physician's judgment, concurrent use of topicalthrombin or other agents is medically advisable, the product literature for that agent shouldbe consulted for complete prescribing information.

Caution: Federal Law restricts this device to sale by or on the order of a physician (or properlylicensed practitioner).