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Tray Insert - 40° Kerrison and Suction Insert

by TeDan Surgical Innovations, Inc.

Part of a family of 89 devices: see the family page

Ref 78782011

Tray Insert - 40° Kerrison and Suction Insert (78782011) is a Class I device made by TeDan Surgical Innovations, Inc., registered in EUDAMED on 16 Mar 2022 (Basic UDI-DI 8430591TRAY8B) and listed in FDA GUDID since 14 Aug 2017 (UDI-DI 00843059104257), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8430591TRAY8B Basic UDI-DI 00843059104257UDI-DIDate16 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00843059104257 UDI-DI Date14 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8430591TRAY8B registered 16 Mar 2022 Active
  • FDA GUDID UDI-DI 00843059104257 listed 14 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843059104257
  2. Registered EUDAMED 8430591TRAY8B

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Tray Insert - 40° Kerrison and Suction Insert EUDAMED
Stryker GUDID
Generic name
Device sterilization/disinfection container, reusable
Device name
Tray
Model / reference
78782011
Primary DI / UDI-DI
00843059104257
Basic UDI-DI
8430591TRAY8B
Direct marketing DI
00843059104257
FDA product code
FSM
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000016933
Authorised representative
TeDan Surgical Innovations B.V. NL-AR-000002696

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

Other devices from TeDan Surgical Innovations, Inc.

See all devices from TeDan Surgical Innovations, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)