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Thompson
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 46170ETModel Thompson Retractor System
Identity
- Trade Name
- Radio Deaver 25x127mm EUDAMEDThompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Radio Deaver 25x127mm FDA UDI
- Model / Reference
- 46170ET EUDAMEDFDA UDIThompson Retractor System EUDAMED
- Description
- Radio Deaver 25x127mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536115758 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536115758 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retraction system, reusable 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: Surgical retraction system, reusable
Thompson by Thompson Surgical Instruments — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- GRACEY 14 TALON TOUGH QUIK TIP — American Eagle Instruments · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Straight stem trial , PSA , Ø10 × 100mm — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · 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 f03af0e1-7efb-4435-bd68-2dfc6011ddb0 34 fields · synced Jun 18, 2026
- EUDAMED 22338bea-0394-42c7-9cc7-ca8b06fa3d75 61 fields · synced Jun 18, 2026