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SportSuite 0203-1000

by Stryker Corp.

SportSuite 0203-1000 is a medical image management system (FDA Class II; FDA product code SIT) made by Stryker Corp., granted FDA De Novo DEN250040 on 17 Jul 2026 and listed in FDA GUDID since 21 Aug 2026 (UDI-DI 07613327651232), active as of 23 Oct 2026.

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

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

De Novo DEN250040

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 Number07613327651232 UDI-DI Date21 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN250040 Date17 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN250040 decided 17 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327651232 listed 21 Aug 2026 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN250040
  2. Listed FDA GUDID 07613327651232

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

GUDID

Trade name
SportSuite
Generic name
Medical image management system
Model / Ref / Catalog
0203-1000
Primary DI / UDI-DI
07613327651232
De Novo Number
FDA product code
SIT
GMDN term
Medical image management system
Device class
Class II
Regulation number
888.1150
GUDID distribution status
In Commercial Distribution

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See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)