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Ambler Surgical Beaver knife handle

by Ambler Surgical, LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190660092412 UDI-DIDate4 Jan 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Ambler Surgical
Generic Name
Scalpel handle, reusable
Model / Ref / Catalog
Beaver knife handle, 38-150
Primary DI / UDI-DI
00190660092412
FDA Product Code
GDZ
GMDN Term
Scalpel handle, reusable
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No