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Thompson Surgical Instruments Lite Path Integrated Double 13mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 40040Model Lite Path Integrated Double 13mm
Identity
- Trade Name
- Thompson Surgical Instruments Lite Path Integrated Double 13mm FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- 40040 EUDAMEDFDA UDILite Path Integrated Double 13mm EUDAMED
Identifiers
- Catalog Number
- 012748 FDA UDI
- Primary DI / UDI-DI
- 00812432023010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432023010 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open surgical site internal light
Thompson Surgical Instruments Lite Path Integrated Double 13mm by Lumitex, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (2)
- FDA UDI 20800298-8d31-421d-985d-e54fb389ab7b 33 fields · synced Jul 8, 2026
- EUDAMED 062a3dbb-4a16-45ad-b321-74e8ae06c8f8 61 fields · synced Jun 18, 2026