Typenex Medical

FDA UDI

Class II (US FDA UDI)

by WEINERT Fiber Optics Inc.

Identity

Trade Name: Typenex Medical FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Model / Reference: NV0632 FDA UDI

Identifiers

Catalog Number: 097509 FDA UDI
Primary DI / UDI-DI: 00816901022580 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General/multiple surgical diode laser system

Typenex Medical by WEINERT Fiber Optics Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: WEINERT Fiber Optics Inc.

Sources (1)

FDA UDI a180b023-0d6a-4806-91f0-b0460f952fdc 33 fields · synced Jun 8, 2026