N/A 68391-Acc

by PENTAX of America, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04961333241972 UDI-DI	Date6 Mar 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Computer terminal
Model / Reference: 68391-ACC

Primary DI / UDI-DI: 04961333241972
FDA Product Code: OUG
GMDN Term: Computer terminal

Device Class: Class I
Regulation Number: 880.6310
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No