devemed

FDA UDI

Class I (US FDA UDI)

by devemed GmbH

Identity

Trade Name: devemed FDA UDI
Generic Name: Mouth gag, adjustable, reusable FDA UDI
Device Name: Mouth Gag "Denhart" FDA UDI
Model / Reference: 1122 FDA UDI
Description: Mouth Gag "Denhart" FDA UDI

Identifiers

Primary DI / UDI-DI: 04061644001798 FDA UDI
FDA Product Code: KBN FDA UDI
GMDN Term: Mouth gag, adjustable, reusable 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

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

Category: Mouth gag, adjustable, reusable

devemed by devemed GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Ambler Surgical — Ambler Surgical, LLC · Class I

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: devemed GmbH

Sources (1)

FDA UDI 64973585-2a66-4848-8848-47e92a9a7442 34 fields · synced Jun 1, 2026