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Awl Ø4.0mm 174025-01

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 Number03760244033604 UDI-DI Date2 Jun 2020ListedStatusListed 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  • Withdrawn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
Awl Ø4.0mm
Generic Name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
174025-01, ROSAS00155
Description
Awl Ø4mm instrument Rosa one 3.1 (spine application) Awl for soft tissues dilation "
Primary DI / UDI-DI
03760244033604
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

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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