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Aligned Medical Solutions AMS12195E

by Aligned Medical Solutions

Aligned Medical Solutions AMS12195E is a Class I device made by Aligned Medical Solutions, listed in FDA GUDID since 23 Oct 2026 (UDI-DI B098AMS12195E0), registry data as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB098AMS12195E0 UDI-DI Date23 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  • Withdrawn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
Neurosurgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
AMS12195E
Primary DI / UDI-DI
B098AMS12195E0
FDA product code
OJG
GMDN term
Neurosurgical procedure kit, non-medicated, single-use
Device class
Class I
Regulation number
882.4525
GUDID distribution status
In Commercial Distribution

Other devices from Aligned Medical Solutions

See all devices from Aligned Medical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (6, all answered No)