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Ambler Surgical 9047E

by Ambler Surgical, LLC

Ambler Surgical 9047E is a Class II device made by Ambler Surgical, LLC, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00190660018924), 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 Number00190660018924 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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 conformer
Model / Ref / Catalog
9047E
Primary DI / UDI-DI
00190660018924
FDA product code
HQN
GMDN term
Ophthalmic conformer
Device class
Class II
Regulation number
886.3130
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code HQN (CONFORMER, OPHTHALMIC).

Other devices from Ambler Surgical, LLC

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Properties

  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)