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Rumex 8-021T

by Rumex International Co.

Rumex 8-021T is a Class I device made by Rumex International Co., listed in FDA GUDID since 3 Jun 2020 (UDI-DI 00840159902110), 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 Number00840159902110 UDI-DI Date3 Jun 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  • Withdrawn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
Rumex
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
8-021T
Primary DI / UDI-DI
00840159902110
FDA product code
FHQ
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
876.4730
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)