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42108h
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 42108HModel Thompson Retractor System
Identity
- Trade Name
- Thompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- 1/2 x 1/2in Snap Spring Joint FDA UDI
- Model / Reference
- Thompson Retractor System EUDAMED42108H EUDAMEDFDA UDI
- Description
- 1/2 x 1/2in Snap Spring Joint FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536127324 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536127324 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
42108h by Thompson Surgical Instruments, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 95d7b51b-6b07-4971-beb6-176b8ad6988d 61 fields · synced Jun 20, 2026
- FDA UDI e81553fb-5b45-4ae7-b84d-e356a240d044 34 fields · synced May 30, 2026