Profiniti

GUDID 00813954025100

Moldable Graft

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954025100
• NIH Device Record Key: b5e34926-8a76-4821-9a7c-11ddd2b887d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profiniti
• Version Model Number: AFMP025
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954025100 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [Profiniti]

• 00813954025117: Moldable Graft
• 00813954025100: Moldable Graft
• 00813954025353: Moldable Putty Bone Graft Matrix
• 00813954025346: Moldable Putty Bone Graft Matrix
• 00813954025339: Moldable Putty Bone Graft Matrix