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Ambler Surgical Bergman mallet

by Ambler Surgical, LLC

Ambler Surgical Bergman mallet (41-092) is a Class I device made by Ambler Surgical, LLC, listed in FDA GUDID since 4 Jan 2021 (UDI-DI 00190660100728), 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 Number00190660100728 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  • Withdrawn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
Surgical mallet
Model / Ref / Catalog
Bergman mallet, 41-092
Primary DI / UDI-DI
00190660100728
FDA product code
GFJ
GMDN term
Surgical mallet
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Similar devices in this category

Other devices filed under Surgical mallet.

Other devices from Ambler Surgical, LLC

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Properties

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