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TLC Self-Retaining Retractor System

FDA UDI

Class I (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
TLC Self-Retaining Retractor System FDA UDI
Generic Name
Hand-held surgical retractor, single-use FDA UDI
Device Name
TLC Disposable Deavers (Sterile, Pouched), MDR FDA UDI
Model / Reference
ETLC601 FDA UDI
Description
TLC Disposable Deavers (Sterile, Pouched), MDR FDA UDI

Identifiers

Catalog Number
ETLC601, TLC601 FDA UDI
Primary DI / UDI-DI
00842071144418 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Hand-held surgical retractor, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held surgical retractor, single-use

TLC Self-Retaining Retractor System by Applied Medical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held surgical retractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (1)

  • FDA UDI 3f6cb90e-73d9-45b0-a13b-6f648dc4f08b 35 fields · synced Jun 9, 2026