Identity
- Trade Name
- TLC Self-Retaining Retractor Stays FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- TLC Retractor Stay, 20mm, 3-Finger Rake, 4-pk (Sterile, Pouched) FDA UDI
- Model / Reference
- ETLC203-4 FDA UDI
- Description
- TLC Retractor Stay, 20mm, 3-Finger Rake, 4-pk (Sterile, Pouched) FDA UDI
Identifiers
- Catalog Number
- ETLC203-4, TLC203-4 FDA UDI
- Primary DI / UDI-DI
- 00842071109653 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable 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: Hand-held surgical retractor, reusableSurgical retractor/retraction system blade, single-useSoft-tissue surgical hook, single-use
TLC Self-Retaining Retractor Stays by Applied Medical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Soft-tissue surgical hook, single-use.
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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 a84a3ea7-79cd-4d7f-9f6b-a91c45f55f9f 35 fields · synced Jun 9, 2026