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WatchTower INS-CBLOCK

by Remex Medical Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719883200532 UDI-DIDate7 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
WatchTower
Generic Name
Neurological stereotactic surgery system
Model / Reference
INS-CBLOCK
Primary DI / UDI-DI
04719883200532
510(k) Number
FDA Product Code
OLO
GMDN Term
Neurological stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K262506)

Show all (10)

Other devices from Remex Medical Corp.

See all devices from Remex Medical Corp. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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