← Back to catalogue

OsteoMatrix

FDA UDI

Class II (US FDA UDI)

by Biostructures

Identity

Trade Name
OsteoMatrix FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Mineralized Collagen Scaffold FDA UDI
Model / Reference
OMCS05 FDA UDI
Description
Mineralized Collagen Scaffold FDA UDI

Identifiers

Catalog Number
OMCS05 FDA UDI
Primary DI / UDI-DI
00852371006095 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial 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
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 10 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

OsteoMatrix by Biostructures — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biostructures

Sources (1)

  • FDA UDI 10b6a8cf-39d1-4517-bb09-4274198ff52b 35 fields · synced Jun 8, 2026