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Cannulated Screwdriver External sleeve 86513

by Premia Spine Ltd GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115932898 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2516-2025 FDA Class II initiated 16 Jul 2025

    Potential for missing pins at tip of inserter.

Specification

GUDID

Trade Name
Cannulated Screwdriver External sleeve
Generic Name
Surgical screwdriver, reusable
Model / Reference
86513
Primary DI / UDI-DI
07290115932898
PMA Number
510(k) Number
FDA Product Code
NKB, MNI, MNH, QWK
GMDN Term
Surgical screwdriver, reusable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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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