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1111-1640

by PENTAX of America Inc.

1111-1640 is a Class II device made by PENTAX of America Inc., listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333231201), registry data as of 8 Nov 2026.

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

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333231201 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Electroglottograph
Model / reference
1111-1640
Primary DI / UDI-DI
04961333231201
FDA product code
KLX
GMDN term
Electroglottograph
Device class
Class II
Regulation number
874.1325
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroglottograph

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)