OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name: OsteoMed FDA UDI
Generic Name: Orthopaedic bone screw starter/notcher FDA UDI
Device Name: 5.6 mm Cannulated Over Drill, Standard AO Quick Release FDA UDI
Model / Reference: 316-1607 FDA UDI
Description: 5.6 mm Cannulated Over Drill, Standard AO Quick Release FDA UDI

Identifiers

Catalog Number: 316-1607 FDA UDI
Primary DI / UDI-DI: 00842528102114 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw starter/notcher FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.6 Millimeter FDA UDI

Category: Orthopaedic bone screw starter/notcher

OsteoMed by Osteomed Corp. — 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: Osteomed Corp.

Sources (1)

FDA UDI 0bb2d013-2222-49b0-86ce-ba6e8c4bf39c 37 fields · synced Jun 1, 2026