Elite Medical Instrumentation

FDA UDI

Class I (US FDA UDI)

by Elite Medical Instrumentation

Identity

Trade Name: ELITE MEDICAL INSTRUMENTATION FDA UDI
Generic Name: Spinal rongeur FDA UDI
Device Name: Kerrison, 40 Up, 1mm, Thin Footplate, 180mm FDA UDI
Model / Reference: EMI-KTS3-01 FDA UDI
Description: Kerrison, 40 Up, 1mm, Thin Footplate, 180mm FDA UDI

Identifiers

Catalog Number: EMI-KTS3-01 FORCEPS FDA UDI
Primary DI / UDI-DI: G569EMIKTS3010 FDA UDI
FDA Product Code: HFB FDA UDI
GMDN Term: Spinal rongeur FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 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

Dimensions & Sizes

Size: Length — 180 Millimeter FDA UDI

Category: Spinal rongeur

Elite Medical Instrumentation by Elite Medical Instrumentation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spinal rongeur.

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Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
V. Mueller — STERIS CORPORATION · Class II
Boss Instruments — Boss Instruments, Ltd. · Class II

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: Elite Medical Instrumentation

Sources (1)

FDA UDI 06e86fa2-2dcd-487f-b4d3-1c5f9b5cf941 35 fields · synced Jun 1, 2026