Skip to content

500-001

by G&H Wire Company, Inc.

500-001 is a Class I device made by G&H Wire Company, Inc., listed in FDA GUDID since 26 Mar 2025 (UDI-DI 10190886101643), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10190886101643 UDI-DI Date26 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Orthodontic separator
Model / reference
500-001
Primary DI / UDI-DI
10190886101643
FDA product code
ECI
GMDN term
Orthodontic separator
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ECI (Band, elastic, orthodontic).

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
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)