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Aligned Medical Solutions AMS16068A

by Aligned Medical Solutions

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB098AMS16068A0 UDI-DI Date12 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  • Withdrawn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
Aligned Medical Solutions
Generic Name
Cardiothoracic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
AMS16068A
Primary DI / UDI-DI
B098AMS16068A0
FDA Product Code
OEZ
GMDN Term
Cardiothoracic surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution

Other devices from Aligned Medical Solutions

See all devices from Aligned Medical Solutions →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No