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Auradonics 811-002NL

by Auradonics Inc.

Auradonics 811-002NL is a Class I device made by Auradonics Inc., listed in FDA GUDID since 2 Jan 2020 (UDI-DI 00810033834615), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810033834615 UDI-DI Date2 Jan 2020ListedStatusListed 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  • Withdrawn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

Trade name
Auradonics
Generic name
Orthodontic inter-arch elastic band
Model / reference
811-002NL
Primary DI / UDI-DI
00810033834615
FDA product code
ECI
GMDN term
Orthodontic inter-arch elastic band
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)