OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name: OsteoMed FDA UDI
Generic Name: Bone tap, single-use, non-sterile FDA UDI
Device Name: 5.5 mm Cannulated Tap, Standard AO Quick Release FDA UDI
Model / Reference: 316-1613 FDA UDI
Description: 5.5 mm Cannulated Tap, Standard AO Quick Release FDA UDI

Identifiers

Catalog Number: 316-1613 FDA UDI
Primary DI / UDI-DI: 00842528102169 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Bone tap, single-use, non-sterile 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

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 — 5.5 Millimeter FDA UDI

Category: Bone tap, single-use, non-sterile

OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, single-use, non-sterile.

TAP, CANCELLOUS, SOLID, S-COUPLE — Biomet Orthopedics, Inc. · Class I
SOLID CANCELLOUS TAP — Biomet Orthopedics, Inc. · Class I
LACTOSORB* 2.0MM SYSTEM — BIOMET MICROFIXATION, INC · Class I
LACTOSORB* 2.0MM SYSTEM — BIOMET MICROFIXATION, INC · Class I
LACTOSORB* SYSTEM — BIOMET MICROFIXATION, INC · Class I
LACTOSORB® 1.5MM SYSTEM — BIOMET MICROFIXATION, INC · Class I
ORTHOSORB LS2.0 mm STRAIGHT PIN KIT, 1 PIN — Biomet Orthopedics, Inc. · Class II
CANNULATED CANCELLOUS TAP — Biomet Orthopedics, Inc. · Class I

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 1b962580-d0d4-4c0a-a581-278a07861498 37 fields · synced Jun 1, 2026