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T7 0416-850-200

by Stryker Corp.

Part of a family of 60 devices: see the family page

Ref 0416-850-200Model 08858250000663S9

T7 0416-850-200 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 08858250000663S9), cleared under FDA 510(k) K200493 on 21 Mar 2020 and listed in FDA GUDID since 11 May 2020 (UDI-DI 07613327465914), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200493

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000663S9 Basic UDI-DI 07613327465914UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327465914 UDI-DI Date11 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200493 Date21 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858250000663S9 registered 20 Jul 2026 Active
  • FDA 510(k) K200493 decided 21 Mar 2020 Active
  • FDA GUDID UDI-DI 07613327465914 listed 11 May 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200493
  2. Listed FDA GUDID 07613327465914
  3. Registered EUDAMED 08858250000663S9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
T7
Generic name
Surgical gown, single-use
Device name
Personal Protective Equipment: Togas & Hoods
Model / Ref / Catalog
0416-850-200, 08858250000663S9
Primary DI / UDI-DI
07613327465914
Basic UDI-DI
08858250000663S9
510(k) Number
FDA product code
FYA
EMDN code
T020499 Surgical gowns - other
GMDN term
Surgical gown, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical gown, single-use

Cleared under the same submission (K200493)

and 8 more cleared under K200493

Similar devices in this category

Other devices filed under SURGICAL GOWNS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)