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Ball Hex Allen Wrench 4mm 151025

by Medtech LLC

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760244030269 UDI-DI Date4 Sep 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ball Hex Allen Wrench 4mm
Generic Name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
151025, ROSAS00188
Description
ball hex allen wrench 4 mm for Rosa One - Application Spine rev-00
Primary DI / UDI-DI
03760244030269
FDA Product Code
OLO
GMDN Term
Multi-purpose 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
MRI Safety
MR Unsafe

Other devices from Medtech LLC

See all devices from Medtech LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Manufacturing Date: No