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Mouthpiece

FDA UDI

Class I (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
MOUTHPIECE FDA UDI
Generic Name
Endoscopic bite block, basic, reusable FDA UDI
Device Name
MA-474 SMALMTHPCE F/GIF-P2/P3 FDA UDI
Model / Reference
MA-474 FDA UDI
Description
MA-474 SMALMTHPCE F/GIF-P2/P3 FDA UDI

Identifiers

Primary DI / UDI-DI
04953170071584 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

Mouthpiece by Olympus Medical Systems 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
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 663eda12-943f-4e07-a6ff-7e458dcd3ee4 34 fields · synced May 30, 2026