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Otv-S700 Upgrade Pack Ir Maj-2512

by Olympus Medical Systems Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number04953170445538 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Otv-S700 Upgrade Pack Ir
Generic Name
Software upgrade/unlocking key
Model / Ref / Catalog
MAJ-2512, N6189540
Primary DI / UDI-DI
04953170445538
510(k) Number
FDA Product Code
OWN, FET, NWB
GMDN Term
Software upgrade/unlocking key
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251336)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No