OsseoSculpt Moldable ABG, 3cc

FDA UDI

Class II (US FDA UDI)

by Biogennix, LLC

Identity

Trade Name: OsseoSculpt Moldable ABG, 3cc FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: OsseoSculpt Moldable ABG, 3cc FDA UDI
Model / Reference: SIN-8C-003-OSC FDA UDI
Description: OsseoSculpt Moldable ABG, 3cc FDA UDI

Identifiers

Primary DI / UDI-DI: 00812593021863 FDA UDI
FDA Product Code: KNW FDA UDI
MQV FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic bone graft Bone marrow biopsy procedure kit

OsseoSculpt Moldable ABG, 3cc by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biogennix, LLC

Sources (1)

FDA UDI b912c01a-d240-4ed7-be3d-c298e5ae8148 33 fields · synced May 30, 2026