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 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 00190776418410 Millennium Avalign Technologies, Inc. GDZ 2026-03-25 09348811000040 INKA The Trustee for KAISER FAMILY TRUST GDZ 2025-11-19 B382SD9045551000 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551010 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551020 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551030 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 16945630137621 index Asurity Sterilance Medical (Suzhou) Inc. GDZ 2025-08-25 16945630137638 index Asurity Sterilance Medical (Suzhou) Inc. GDZ 2025-08-25 38886354702639 Anzen Safety Scalpel MEDIPURPOSE PTE. LTD. GDZ 2025-02-12 B382SD904320210 Surgical Direct Surgical Direct, Inc. GDZ 2024-07-11 M944AL019130 Wexler Surgical, Inc. WEXLER SURGICAL, INC. GDZ 2024-02-12 M944AL019230 Wexler Surgical, Inc. WEXLER SURGICAL, INC. GDZ 2024-02-12 14026704922991 PILLING TELEFLEX INCORPORATED GDZ 2023-11-07 10620974003318 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003325 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003332 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003349 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003356 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 G25001001030 Scalpel Handle No.3 N S SURGICAL COMPANY GDZ 2023-01-31 G25001002040 Scalpel Handle No.4 N S SURGICAL COMPANY GDZ 2023-01-31 07708626670395 SAMPEDRO INDUSTRIAS MEDICAS SAMPEDRO S A S GDZ 2023-01-18 B356BH103010 American Medicals American Medicals GDZ 2023-01-02 00386120012230 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012247 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012254 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012261 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09