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RZ Medizintechnik GmbH

FDA UDI

Class I (US FDA UDI)

by RZ-Medizintechnik GmbH

Identity

Trade Name
RZ Medizintechnik GmbH FDA UDI
Generic Name
Tongue depressor, surgical FDA UDI
Device Name
Bruenings Tongue Depressor 190mm, 7 1/2" FDA UDI
Model / Reference
430-385-190 FDA UDI
Description
Bruenings Tongue Depressor 190mm, 7 1/2" FDA UDI

Identifiers

Catalog Number
430-385-190 FDA UDI
Primary DI / UDI-DI
04049197320870 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tongue depressor, surgical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Tongue depressor, surgical

This Tongue Depressor, or instrument for displace and maintain the tongue in a fixed position, is a reusable device used in oral surgery. The Tongue Depressor from RZ Medizintechnik GmbH is designed with a metallic handle and serrated distal end to safely depress the tongue during surgical procedures.

Similar devices

Also classified as Tongue depressor, surgical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RZ-Medizintechnik GmbH

Sources (1)

  • FDA UDI 37a9b987-aa36-4d94-af4b-6b2d8971a60c 35 fields · synced Oct 7, 2026