Home GUDID B3561116493ST1 American Medicals
Primary DI B3561116493ST1
Brand American Medicals
Company American Medicals
Model 1
Published 2022-09-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GDZ Handle, Scalpel
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDZ Handle, Scalpel General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B3561116493ST1 Package HIBCC 25 In Commercial Distribution B3561116493ST0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Scalpel handle, single-use A sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device.
Regulatory Flags# DUNS number 109909627 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850083275563 Intrace USA PILOTIS TECH LLC GDZ 2026-07-03 00810055255689 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255696 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255702 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255726 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255788 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255801 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255825 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055255863 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256105 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256112 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256129 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256136 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256150 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256174 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256181 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256198 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810055256204 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00810189455139 Surgical Design Surgical Design, Inc. GDZ 2026-06-26 00190776421847 Millennium Avalign Technologies, Inc. GDZ 2026-06-25 00810055257348 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257355 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257362 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257379 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257386 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257850 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00190776421533 Millennium Avalign Technologies, Inc. GDZ 2026-05-05 00190776419769 Millennium Avalign Technologies, Inc. GDZ 2026-04-15 00190776419776 Millennium Avalign Technologies, Inc. GDZ 2026-04-15 00190776419783 Millennium Avalign Technologies, Inc. GDZ 2026-04-15