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Ambler Surgical Maddox LASIK spatula

by Ambler Surgical, LLC 2 variants

Ambler Surgical Maddox LASIK spatula (6902E) is an ocular hook/spatula/manipulator (FDA Class I; FDA product code HND, Spatula, ophthalmic) made by Ambler Surgical, LLC, listed in FDA GUDID since 4 Jan 2021 (UDI-DI 00190660175597), 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 Number00190660175597 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  • Withdrawn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
Ocular hook/spatula/manipulator, reusable
Model / Ref / Catalog
Maddox LASIK spatula, 6902E
Primary DI / UDI-DI
00190660175597
FDA product code
HND
GMDN term
Ocular hook/spatula/manipulator, 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: Ocular hook/spatula/manipulator, reusable

Similar devices in this category

Other devices filed under Ocular hook/spatula/manipulator, reusable.

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Properties

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