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nCare 1006537

by Gyrus Acmi, 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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810008180952 UDI-DI Date19 Dec 2022ListedStatusListed 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  • Withdrawn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
nCare
Generic name
Endoscopic video image processing unit
Model / reference
1006537
Primary DI / UDI-DI
00810008180952
FDA product code
LMB, LMD
GMDN term
Endoscopic video image processing unit
Device class
Class I
Regulation number
892.2010, 892.2020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic video image processing unit

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No