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Fujifilm

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscopic bite block, basic, reusable FDA UDI
Device Name
This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes. FDA UDI
Model / Reference
MPC-P FDA UDI
Description
This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410333251 FDA UDI
FDA Product Code
MNK FDA UDI
GMDN Term
Endoscopic bite block, basic, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 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

Category: Endoscopic bite block, basic, reusable

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

Similar devices

Also classified as Endoscopic bite block, basic, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 39b98f4c-fdf6-46ac-b79e-cc0359a61d3f 35 fields · synced May 30, 2026