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General Instrument 01-1200-0102

by Orthopediatrics Corp.

Ref 01-1200-0102Model 01-1007-0007

General Instrument 01-1200-0102 is a Class I device made by Orthopediatrics Corp., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 08411321CIRINSTCE) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00841132127711), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIRINSTCE Basic UDI-DI 00841132127711UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132127711 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIRINSTCE registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00841132127711 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132127711
  2. Registered EUDAMED 08411321CIRINSTCE

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  • Withdrawn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
01-1200-0102, 01-1007-0007
Primary DI / UDI-DI
00841132127711
Basic UDI-DI
08411321CIRINSTCE
FDA product code
FZX
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I
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 · 1 field differs

FieldEUDAMEDGUDID
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 00841132127711: EUDAMED states Yes, FDA GUDID states No.

Related devices

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

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - 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)