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General Instrument 11-1500-005

by Orthopediatrics Corp.

Ref 11-1500-005

General Instrument 11-1500-005 is a device classified as Class IIa in the EU and Class I in the US made by Orthopediatrics Corp., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 08411321CIIAETS67) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00841132128626), 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 Number08411321CIIAETS67 Basic UDI-DI 00841132128626UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132128626 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIAETS67 registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 00841132128626 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132128626
  2. Registered EUDAMED 08411321CIIAETS67

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  • Withdrawn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 surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
11-1500-005
Primary DI / UDI-DI
00841132128626
Basic UDI-DI
08411321CIIAETS67
FDA product code
LXH
EMDN code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 00841132128626: 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 surgical procedure kit, non-medicated, 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)