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Ambler Surgical #7 knife handle

by Ambler Surgical, LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190660092382 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  • Withdrawn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
#7 knife handle, 38-130
Primary DI / UDI-DI
00190660092382
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

Related devices

Category: Scalpel handle, reusable

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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