Spandex Advanced Kit ( 1 Standard/ 1 Large)

FDA UDI

Class I (US FDA UDI)

by Hager Worldwide, Inc.

Identity

Trade Name: Spandex Advanced Kit ( 1 Standard/ 1 Large) FDA UDI
Generic Name: Dental cheek retractor, professional, reusable FDA UDI
Device Name: lip and cheeck retractor FDA UDI
Model / Reference: 605460 FDA UDI
Description: lip and cheeck retractor FDA UDI

Identifiers

Primary DI / UDI-DI: D2486054601 FDA UDI
FDA Product Code: EIF FDA UDI
GMDN Term: Dental cheek retractor, professional, reusable 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental cheek retractor, professional, reusable

Spandex Advanced Kit ( 1 Standard/ 1 Large) by Hager Worldwide, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental cheek retractor, professional, reusable.

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GoldenDent — GoldenDent · Class I
Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
Power Dental USA — Power Dental USA, Inc. · 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: Hager Worldwide, Inc.

Sources (1)

FDA UDI 5f7f5b73-2e57-4ce0-babf-77e668651f8b 34 fields · synced Jun 9, 2026