Home GUDID 00841645119722 ASSI
Primary DI 00841645119722
Brand ASSI
Company ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model ASSI.15626
Device description Dingman type Otoabrader Rasp Left & Right curved, 15.5cm(2 INST. PER PKG) 10 teeth over a 5mm spread
Published 2020-06-25
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 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 00841645119722 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841645119722 00841645119722 841645119722 0841645119722
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, manual A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 055870299 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true 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 table 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