Dental City

FDA UDI

Class II (US FDA UDI)

by Icp, Inc.

Identity

Trade Name: Dental City FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Tray Sleeve A Chayes 11 5/8X14.5 FDA UDI
Model / Reference: 50-577 FDA UDI
Description: Tray Sleeve A Chayes 11 5/8X14.5 FDA UDI

Identifiers

Primary DI / UDI-DI: D77150577 FDA UDI
FDA Product Code: PEM FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Medical equipment/instrument drape, single-use

Dental City by Icp, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Medical equipment/instrument drape, single-use.

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MICROTEK — Microtek Medical LLC · Class II
Plasdent — PLASDENT CORP. · Class II
Probe Cover — Advance Medical Designs, Inc. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Icp, Inc.

Sources (1)

FDA UDI dc5e199e-4534-4ac7-9c70-7b9ad173972c 33 fields · synced Jun 8, 2026