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Genesis™ 13 CHG EXT 205009

by Prentke Romich Company

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816486021671 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Genesis™ 13 CHG EXT
Generic Name
Voice synthesizer/digitizer
Model / Reference
205009
Primary DI / UDI-DI
00816486021671
FDA Product Code
ILQ
GMDN Term
Voice synthesizer/digitizer
Device Class
Class II
Regulation Number
890.3710
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Over-the-Counter
  • Premarket Exempt

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No