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Thompson
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 64049Model Thompson Retractor System
Identity
- Trade Name
- Silicone Sleeve Large EUDAMEDThompson FDA UDI
- Generic Name
- Radial surgical retractor FDA UDI
- Device Name
- Silicone Sleeve Large FDA UDI
- Model / Reference
- 64049 EUDAMEDFDA UDIThompson Retractor System EUDAMED
- Description
- Silicone Sleeve Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536101928 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536101928 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Radial surgical retractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Radial surgical retractor
Thompson by Thompson Surgical Instruments — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radial surgical retractor.
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- CleanCision Wound Retraction and Protection System — Prescient Surgical, Inc. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments
Sources (2)
- FDA UDI db686dc9-c210-432f-bc43-8da9589e7fad 34 fields · synced Jun 19, 2026
- EUDAMED 47b91710-d58a-4a53-a8f6-ef06da9ec16d 61 fields · synced Jun 19, 2026