Aesculap

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: AESCULAP FDA UDI
Generic Name: Hand-held dental retractor FDA UDI
Device Name: KIRSCH Cheek Retractor, curved to right, 8 1/4", (210 mm), depth: 60 mm, width: 11 mm, non-sterile, reusable FDA UDI
Model / Reference: DO441R FDA UDI
Description: KIRSCH Cheek Retractor, curved to right, 8 1/4", (210 mm), depth: 60 mm, width: 11 mm, non-sterile, reusable FDA UDI

Identifiers

Catalog Number: DO441R FDA UDI
Primary DI / UDI-DI: 04038653148615 FDA UDI
FDA Product Code: EIG FDA UDI
GMDN Term: Hand-held dental retractor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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: Hand-held dental retractor

Aesculap by Aesculap, 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: Aesculap, Inc.

Sources (1)

FDA UDI aec651b5-6e17-4d50-a3d7-2b39740a7025 35 fields · synced Jun 6, 2026