Orthomed

FDA UDI

Class I (US FDA UDI)

by Ortho-Med, Inc.

Identity

Trade Name: ORTHOMED FDA UDI
Generic Name: Pinwheel aesthesiometer FDA UDI
Device Name: WARTENBERG PIN WHEEL 7" FDA UDI
Model / Reference: OM 28-0514 FDA UDI
Description: WARTENBERG PIN WHEEL 7" FDA UDI

Identifiers

Primary DI / UDI-DI: B8032805140 FDA UDI
FDA Product Code: GWY FDA UDI
GMDN Term: Pinwheel aesthesiometer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.1750 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Pinwheel aesthesiometer

Orthomed by Ortho-Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BR Surgical, LLC — BR SURGICAL LLC · Class I
Novo Surgical — NOVO SURGICAL, INC. · Class I
gSource — GSOURCE, LLC. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
V. Mueller — STERIS CORPORATION · 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 I	Pending data

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Manufacturer

Manufacturer: Ortho-Med, Inc.

Sources (1)

FDA UDI c8ffb2c4-722c-4f89-9dae-89b57c7b9058 33 fields · synced Jun 6, 2026