Zoll-Dental

FDA UDI

Class I (US FDA UDI)

by Zoll-Dental

Identity

Trade Name: ZOLL-DENTAL FDA UDI
Generic Name: Hand-held dental retractor FDA UDI
Device Name: DeMarres Lip & Cheek Retractor, Large FDA UDI
Model / Reference: Z-9500 FDA UDI
Description: DeMarres Lip & Cheek Retractor, Large FDA UDI

Identifiers

Primary DI / UDI-DI: 00840105221098 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

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

Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
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STOMA® — Storz am Mark GmbH · Class I
DIOnavi. Scan Retractor Lower jaw — DIO Corporation · 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: Zoll-Dental

Sources (1)

FDA UDI 46126a4c-b9d5-430e-baa6-04b571cffae8 34 fields · synced Jun 1, 2026