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Scopis 8000-021-002

by Stryker Leibinger

Scopis 8000-021-002 is a Class II device made by Stryker Leibinger, listed in FDA GUDID since 19 Oct 2022 (UDI-DI 07613327514179), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327514179 UDI-DI Date19 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Scopis
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog
8000-021-002
Primary DI / UDI-DI
07613327514179
FDA product code
PGW
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)