Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED INCORPORATED FDA UDI
Generic Name: Craniofacial rongeur, reusable FDA UDI
Device Name: Kerrison Rongeur, Micro, 8" (200mm), 2.5mm, 40° up, Pin Ejector, Ceramic FDA UDI
Model / Reference: CC8-2.5MM40PIN FDA UDI
Description: Kerrison Rongeur, Micro, 8" (200mm), 2.5mm, 40° up, Pin Ejector, Ceramic FDA UDI

Identifiers

Catalog Number: CC8-2.5MM40PIN FDA UDI
Primary DI / UDI-DI: 00198506083914 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Craniofacial rongeur, reusable 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial rongeur, reusable

Elmed Incorporated by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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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: Elmed Incorporated

Sources (1)

FDA UDI 39dbeff3-3c6e-4902-b64f-6cb6b79e1bf8 35 fields · synced May 31, 2026