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G4™

by G&H Wire Company, Inc.

Part of a family of 14 devices: see the family page

Ref G4BF112

G4™ (G4BF112) is a device classified as Class IIa in the EU and Class I in the US made by G&H Wire Company, Inc., registered in EUDAMED on 16 Sep 2022 (Basic UDI-DI 0190886Type2Orthowires43) and listed in FDA GUDID since 26 Mar 2025 (UDI-DI 10190886033890), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10190886033890 UDI-DI Date26 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0190886Type2Orthowires43 Basic UDI-DI 10190886033890UDI-DIDate16 Sep 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0190886Type2Orthowires43 registered 16 Sep 2022 Active
  • FDA GUDID UDI-DI 10190886033890 listed 26 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0190886Type2Orthowires43
  2. Listed FDA GUDID 10190886033890

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  • Withdrawn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
G4™ EUDAMED
G4 Nickel Titanium GUDID
Generic name
Orthodontic archwire
Device name
Orthodontic Wire
Model / reference
G4BF112
Primary DI / UDI-DI
10190886033890
Basic UDI-DI
0190886Type2Orthowires43
Unit of use DI
00190886033893
FDA product code
DZC
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic archwire
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — .012 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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.

Manufacturer details

EUDAMED SRN
US-MF-000012129
Authorised representative
G&H Europe BV NL-AR-000022839

Similar devices in this category

Other devices filed under ORTHODONTIC WIRES.

Other devices from G&H Wire Company, Inc.

See all devices from G&H Wire Company, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)