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Mts™ 1183

by St. Jude Medical, Inc.

Mts™ 1183 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K033757 on 30 Jan 2004 and listed in FDA GUDID since 25 Apr 2015 (UDI-DI 05414734400596), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K033757

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734400596 UDI-DI Date25 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033757 Date30 Jan 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033757 decided 30 Jan 2004 Active
  • FDA GUDID UDI-DI 05414734400596 listed 25 Apr 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033757
  2. Listed FDA GUDID 05414734400596

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mts™
Generic name
Personal device holder, reusable
Model / Ref / Catalog
1183
Primary DI / UDI-DI
05414734400596
510(k) Number
FDA product code
GZB
GMDN term
Personal device holder, reusable
Device class
Class II
Regulation number
882.5880
GUDID distribution status
In Commercial Distribution

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)