Skip to content

Na 37100008

by Sinovation (Beijing) Medical Technology Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974813830199 UDI-DI Date31 Aug 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Neurological stereotactic surgery system
Model / Reference
37100008
Primary DI / UDI-DI
06974813830199
510(k) Number
FDA Product Code
HAW
GMDN Term
Neurological stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Neurological stereotactic surgery system

Cleared under the same submission (K220072)

Show all (12)

Other devices from Sinovation (Beijing) Medical Technology Co., Ltd.

See all devices from Sinovation (Beijing) Medical Technology Co., Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No