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Ambler Surgical Castroviejo needle holder

by Ambler Surgical, LLC 106 variants

Ambler Surgical Castroviejo needle holder (4408E) is a suturing needle holder (FDA Class I; FDA product code HNR, Forceps, ophthalmic) made by Ambler Surgical, LLC, listed in FDA GUDID since 4 Jan 2021 (UDI-DI 00190660114015), 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 Number00190660114015 UDI-DI Date4 Jan 2021ListedStatusListed 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  • Withdrawn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
Ambler Surgical
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
Castroviejo needle holder, 4408E
Primary DI / UDI-DI
00190660114015
FDA product code
HNR
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
886.4350
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Suturing needle holder, reusable

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Other devices filed under Suturing needle holder, reusable.

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Properties

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