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8800-012-000

by Stryker Leibinger

8800-012-000 is a Class II device made by Stryker Leibinger, listed in FDA GUDID since 13 Oct 2025 (UDI-DI 07613327579864), 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 Number07613327579864 UDI-DI Date13 Oct 2025ListedStatusListed 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  • Withdrawn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

Generic name
Stereotactic surgery system probe, reusable
Model / Ref / Catalog
8800-012-000
Primary DI / UDI-DI
07613327579864
FDA product code
OLO
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code OLO (Orthopedic stereotaxic instrument).

Other devices from Stryker Leibinger

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  • 92-55771

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  • 92-55770

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See all devices from Stryker Leibinger →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)