Orthomed

FDA UDI

Class I (US FDA UDI)

by Ortho-Med, Inc.

Identity

Trade Name: ORTHOMED FDA UDI
Generic Name: Orthopaedic joint/limb rongeur FDA UDI
Device Name: LEKSELL RONGEUR 9" 4X16MM 15DEG CVD FDA UDI
Model / Reference: OM 47-0486 FDA UDI
Description: LEKSELL RONGEUR 9" 4X16MM 15DEG CVD FDA UDI

Identifiers

Primary DI / UDI-DI: B8034704860 FDA UDI
FDA Product Code: HTX FDA UDI
GMDN Term: Orthopaedic joint/limb rongeur FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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: Orthopaedic joint/limb rongeur

Orthomed by Ortho-Med, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Ortho-Med, Inc.

Sources (1)

FDA UDI 2adf112e-fd1e-471f-905a-beeba054a2ed 33 fields · synced May 31, 2026