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Na Druj-SC20

by Aptis Medical, LLC.

Ref DRUJ-SC20

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B013DRUJSC200 Basic UDI-DI B013DRUJSC200UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB013DRUJSC200 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
DRUJ-SC20
Primary DI / UDI-DI
B013DRUJSC200
Basic UDI-DI
B-B013DRUJSC200
FDA Product Code
KXE
EMDN Code
P09120601 Cortical screws
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3810
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Length — 20 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone screw (non-sliding)

Other devices from Aptis Medical, LLC.

See all devices from Aptis Medical, LLC. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Implantable
  • Lot / Batch Number

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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
  • Manufacturing Date: No