Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope calibration cover, reusable FDA UDI
- Device Name
- This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes. FDA UDI
- Model / Reference
- CB-01B FDA UDI
- Description
- This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410524284 FDA UDI
- FDA Product Code
- NWV FDA UDI
- GMDN Term
- Endoscope calibration cover, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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: Endoscope calibration cover, reusable
Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope calibration cover, reusable.
- White cap — Olympus Medical Systems Corporation · Class II
- WHITE CAP SET — Olympus Medical Systems Corporation · Class II
- PENTAX — HOYA CORPORATION · Class II
- PENTAX — HOYA CORPORATION · Class II
- WHITE CAP HOLDER — Olympus Medical Systems Corporation · Class II
- White cap set — Olympus Medical Systems Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI 6c3784b8-6af9-42a1-bf5b-36440daebf08 34 fields · synced May 30, 2026