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Aligned Medical Solutions AMS1985B

by Aligned Medical Solutions

Aligned Medical Solutions AMS1985B is a rectal ultrasound navigational image processor (FDA Class II; FDA product code OHD, Gynecological Laparoscopic Kit) made by Aligned Medical Solutions, listed in FDA GUDID since 26 Jul 2023 (UDI-DI B098AMS1985B0), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB098AMS1985B0 UDI-DI Date26 Jul 2023ListedStatusListed 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  • Withdrawn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
Aligned Medical Solutions
Generic name
Rectal ultrasound navigational image processor
Model / Ref / Catalog
AMS1985B
Primary DI / UDI-DI
B098AMS1985B0
FDA product code
OHD
GMDN term
Rectal ultrasound navigational image processor
Device class
Class II
Regulation number
884.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rectal ultrasound navigational image processor

Other devices from Aligned Medical Solutions

See all devices from Aligned Medical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)