Bone Mill Hammer

FDA UDIEUDAMED

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name: Bone Mill Hammer FDA UDI
Generic Name: Manual bone mill FDA UDI
Model / Reference: ABMH FDA UDI

Identifiers

Primary DI / UDI-DI: 08800000929606 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Manual bone mill FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual bone mill

Bone Mill Hammer by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Manual bone mill.

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BONE MILL SET — SONTEC INSTRUMENTS, INC. · Class I
Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
BONE MILL — KLS-Martin L.P. · Class I
BONE GRINDER — SONTEC INSTRUMENTS, INC. · Class I
Milling Drum Extra Extra Coarse — Spierings Orthopaedics B.V. · Class I
Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: OSSTEM IMPLANT Co., Ltd.

Sources (2)

FDA UDI 4ac8e5cc-77af-4aba-9db8-7baa824c4035 32 fields · synced Jun 17, 2026
EUDAMED 1 fields · synced Jun 2, 2026