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4.5mm Depth Gauge, Outer Sleeve Assembly 10-100mm 01-9000-4502

by Orthopediatrics Corp.

Ref 01-9000-4502Model 01-1007-0007

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

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIRINSTCE Basic UDI-DI 00841132178669UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132178669 UDI-DI Date21 Jun 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Orthopediatrics® Instrumentation EUDAMED
4.5mm Depth Gauge, Outer Sleeve Assembly 10-100mm GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
01-9000-4502, 01-1007-0007
Primary DI / UDI-DI
00841132178669
Basic UDI-DI
08411321CIRINSTCE
FDA Product Code
HTJ
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
888.4300
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No