Orthomed

FDA UDI

Class II (US FDA UDI)

by Ortho-Med, Inc.

Identity

Trade Name: ORTHOMED FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: STEIN.PIN S.TROC.TH.9"9/64"3.5MM FDA UDI
Model / Reference: OM 71-0782R FDA UDI
Description: STEIN.PIN S.TROC.TH.9"9/64"3.5MM FDA UDI

Identifiers

Catalog Number: OM 71-0782R FDA UDI
Primary DI / UDI-DI: B803710782R0 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Orthomed by Ortho-Med, Inc. — 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: Ortho-Med, Inc.

Sources (1)

FDA UDI 4a40d3c3-c5a2-4f53-b4be-d0ee37dacd15 35 fields · synced Jun 7, 2026