Skip to content

General Instrument 11-1500-002

by Orthopediatrics Corp.

Part of a family of 25 devices: see the family page

Ref 11-1500-002Model 01-1010-007

General Instrument 11-1500-002 is a device classified as Class IIa in the EU and Class I in the US made by Orthopediatrics Corp., registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 08411321CIIAGWNRCP) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00841132128619), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIIAGWNRCP Basic UDI-DI 00841132128619UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132128619 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIAGWNRCP registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI 00841132128619 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132128619
  2. Registered EUDAMED 08411321CIIAGWNRCP

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  • Withdrawn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
General Instrument GUDID
Generic name
Orthopaedic guidewire, reusable
Model / Ref / Catalog
11-1500-002, 01-1010-007
Primary DI / UDI-DI
00841132128619
Basic UDI-DI
08411321CIIAGWNRCP
FDA product code
FZX
EMDN code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Orthopaedic guidewire, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841132128619: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic guidewire, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)