Identity
- Trade Name
- TLC Self-Retaining Retractor System FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDI
- Device Name
- TLC Male Urology Retractor System with Frame (Boxed) FDA UDI
- Model / Reference
- TLC5010 FDA UDI
- Description
- TLC Male Urology Retractor System with Frame (Boxed) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842071112271 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, 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
No
FDA UDI
Category: Surgical retractor/retraction system blade, single-useSurgical retraction system mounting frame, reusable
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 Surgical retraction system mounting frame, reusable.
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- Novo Surgical — NOVO SURGICAL, INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- Retractor, Spinal, blade, acc. Honolulu toothed 15x40mm — Geister Medizin Technik GmbH · Class II
- Hayden Medical — Hayden Medical Inc · Class I
- Retractor, Spinal, ring-handle, Längs with hinge with catch — Geister Medizin Technik GmbH · Class II
- Retractor, Spinal, quick-connect Blade medial/lateral 19x60mm prongs — Geister Medizin Technik GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI 615799ca-2d14-4add-a2d5-b3f89f5e3b18 34 fields · synced Jun 9, 2026