← Back to catalogue

IRM - 2.5cc

FDA UDI

Class II (US FDA UDI)

by NovaBone Products, LLC

Identity

Trade Name
IRM - 2.5cc FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Synthetic bone void filler for orthopedic applications FDA UDI
Model / Reference
NP0602 FDA UDI
Description
Synthetic bone void filler for orthopedic applications FDA UDI

Identifiers

Catalog Number
NP0602 FDA UDI
Primary DI / UDI-DI
00813909011646 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

Category: Bone matrix implant, synthetic, non-antimicrobial

IRM - 2.5cc by NovaBone Products, LLC — 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
NovaBone Products, LLC

Sources (1)

  • FDA UDI d3237331-8af5-4427-8273-a253d6a3cbf9 36 fields · synced Jun 9, 2026