← Back to catalogue
THD Opti-Fiber (Revo/BT)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 880012Model THD Opti-Fiber
by Thd S.p.a.
Identity
- Trade Name
- THD Opti-Fiber (Revo/BT) EUDAMEDTHD SLIDE ONE FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- THD Opti-Fiber EUDAMEDThe THD 880012 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument. FDA UDI
- Model / Reference
- THD Opti-Fiber EUDAMED880012 EUDAMEDTHD OPTI-FIBER (REVO/BT) FDA UDI
- Description
- The THD 880012 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument. FDA UDI
Identifiers
- Catalog Number
- 880012 FDA UDI
- Primary DI / UDI-DI
- 08033737710777 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771FOC000176 EUDAMED
- 510(k) Number
- K090009 FDA UDI
- FDA Product Code
- JAF FDA UDI
- EMDN Code
- Z12019080 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
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
No
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
THD Opti-Fiber (Revo/BT) by Thd S.p.a. — Class I — 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 | 803373771FOC000176 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-MF-000029427
Sources (2)
- EUDAMED 76543d10-250c-4938-bb5a-a9e75f6de460 61 fields · synced Jul 17, 2026
- FDA UDI 3be1aec2-ecb4-4f76-abad-d4efb7f7ec86 36 fields · synced May 30, 2026