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Integra® Miltex® 8-42

by Integra LifeSciences Production Corporation

Integra® Miltex® 8-42 is a Class I device made by Integra LifeSciences Production Corporation, listed in FDA GUDID since 16 Aug 2018 (UDI-DI 10381780478843), 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 Number10381780478843 UDI-DI Date16 Aug 2018ListedStatusListed 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  • Withdrawn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
Integra® Miltex®
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
8-42
Primary DI / UDI-DI
10381780478843
FDA product code
FHQ
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
876.4730
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)