Home GUDID D955BGC0011 Paul Banditt
Primary DI D955BGC0011
Brand Paul Banditt
Company Terlain Enterprises, Inc.
Model BLAH3R
Device description Scalpel handles No. 3 with scale
Published 2023-12-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes Code Name GDZ Handle, Scalpel
Product Code Classifications Code Device Specialty Class GDZ Handle, Scalpel General, Plastic Surgery 1
Identifiers And Packaging Identifier Type Agency Package quantity Status D955BGC0011 Primary HIBCC 0
GMDN Terms Term Definition Scalpel handle, reusable A 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 reusable device.
Sterilization Methods Method Moist Heat or Steam Sterilization
Regulatory Flags DUNS number 177465051 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company Other Devices Sharing Product Codes Primary DI Brand Company Product code Published 00190776418038 Millennium Avalign Technologies, Inc. GDZ 2026-03-23 16937372521523 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 16937372521530 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 16937372521547 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 16937372521554 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 16937372521561 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 16937372521578 comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. GDZ 2026-03-19 B382SD914010350 Surgical Direct Surgical Direct, Inc. GDZ 2026-02-25 B382SD4811280 Surgical Direct Surgical Direct, Inc. GDZ 2026-02-16 00190776416157 Millennium Avalign Technologies, Inc. GDZ 2026-02-06 00840124525320 FuzeFix Mini FUSION ORTHOPEDICS, LLC GDZ 2026-02-03 00840124525337 FuzeFix Mini FUSION ORTHOPEDICS, LLC GDZ 2026-02-03 09348811000019 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000095 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000132 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000149 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000170 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000187 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000194 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000200 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000217 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811000224 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811014146 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811014856 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811014863 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 09348811151452 INKA The Trustee for KAISER FAMILY TRUST GDZ 2026-01-30 00840124525245 FuzeFix Mini FUSION ORTHOPEDICS, LLC GDZ 2026-01-22 00841013120480 Otto Leibinger AMERICAN EAGLE INSTRUMENTS, INC. GDZ 2026-01-06 00841013124327 American Eagle Instruments AMERICAN EAGLE INSTRUMENTS, INC. GDZ 2026-01-02 00841013124334 American Eagle Instruments AMERICAN EAGLE INSTRUMENTS, INC. GDZ 2026-01-02