Skip to content

Na Druj-B1020

by Aptis Medical, LLC.

Listed FDA GUDID listing, no authorization on record

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 NumberB013DRUJB10200 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Wrist ulna-head prosthesis
Model / Ref / Catalog
DRUJ-B1020
Primary DI / UDI-DI
B013DRUJB10200
FDA Product Code
KXE
GMDN Term
Wrist ulna-head prosthesis
Device Class
Class II
Regulation Number
888.3810
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Conditional

Related devices

Category: Wrist ulna-head prosthesis

Other devices from Aptis Medical, LLC.

See all devices from Aptis Medical, LLC. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • 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
  • Manufacturing Date: No