Klein Surgical

FDA UDI

Class I (US FDA UDI)

by Klein Surgical Systems, Inc.

Identity

Trade Name: Klein Surgical FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Klein Sterilization Tray FDA UDI
Model / Reference: GI3000 FDA UDI
Description: Klein Sterilization Tray FDA UDI

Identifiers

Catalog Number: GI3000 FDA UDI
Primary DI / UDI-DI: 10850048763644 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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

Dimensions & Sizes

Size: Length — 190.5 Millimeter FDA UDI
Width — 101.6 Millimeter FDA UDI
Height — 20.32 Millimeter FDA UDI

Category: Instrument tray, reusable

Klein Surgical by Klein Surgical Systems, 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: Klein Surgical Systems, Inc.

Sources (1)

FDA UDI a975b69a-93ea-4f66-872b-e709d7930861 36 fields · synced Jun 8, 2026