Collage Osteoconductive Scaffold - Putty 710005

GUDID 10381780112044

The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

Integra Lifesciences Corporation

Bone matrix implant, composite
Primary Device ID10381780112044
NIH Device Record Keyf3668154-6cd8-465e-a3d1-62b248a14900
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollage Osteoconductive Scaffold - Putty
Version Model Number710005
Catalog Number710005
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780112044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-16
Device Publish Date2015-10-16

On-Brand Devices [Collage Osteoconductive Scaffold - Putty]

10381780112068The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
10381780112051The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
10381780112044The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
M2697100151The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
M2697100101The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b
M2697100051The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable b

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