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Ambler Surgical Hu capsule polishing curette

by Ambler Surgical, LLC 2 variants

Ambler Surgical Hu capsule polishing curette (5477E) is a Class I device made by Ambler Surgical, LLC, listed in FDA GUDID since 7 Jan 2021 (UDI-DI 00190660008093), 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 Number00190660008093 UDI-DI Date7 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  • Withdrawn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
Ophthalmic curette, reusable
Model / Ref / Catalog
Hu capsule polishing curette, 5477E
Primary DI / UDI-DI
00190660008093
FDA product code
HNZ
GMDN term
Ophthalmic curette, 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: Ophthalmic curette, reusable

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Other devices filed under Ophthalmic curette, reusable.

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Properties

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