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Profiniti

FDA UDI

Class II (US FDA UDI)

by Collagen Matrix, Inc.

Identity

Trade Name
Profiniti FDA UDI
Generic Name
Bone matrix implant, animal-derived, bioabsorbable FDA UDI
Device Name
Moldable Graft FDA UDI
Model / Reference
AFMP025 FDA UDI
Description
Moldable Graft FDA UDI

Identifiers

Primary DI / UDI-DI
00813954025100 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, animal-derived, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone matrix implant, animal-derived, bioabsorbable

Profiniti by Collagen Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, animal-derived, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Collagen Matrix, Inc.

Sources (1)

  • FDA UDI b5e34926-8a76-4821-9a7c-11ddd2b887d1 34 fields · synced Jun 8, 2026