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45003gs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 45003GSModel Thompson Retractor System
Identity
- Trade Name
- Thompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- QA Handle 8in FDA UDI
- Model / Reference
- Thompson Retractor System EUDAMED45003GS EUDAMEDFDA UDI
- Description
- QA Handle 8in FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536126112 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536126112 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
45003gs by Thompson Surgical Instruments — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 008415361TRMR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments, Inc.
- EUDAMED SRN
- US-MF-000013232
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2bb43d7c-3537-4c12-a759-2394143710a9 61 fields · synced Jun 17, 2026
- FDA UDI 59e52cd6-118c-4ed6-b190-a43bf534e197 34 fields · synced May 30, 2026