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Fujifilm

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscope calibration cover, single-use 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-01P 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
04547410515893 FDA UDI
FDA Product Code
NWV FDA UDI
GMDN Term
Endoscope calibration cover, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope calibration cover, single-use

Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 40ee79c8-7d5c-4cd8-b004-6d9f1438a8da 34 fields · synced May 30, 2026