Home GUDID 00810131880729 Bone Chisel
Primary DI 00810131880729
Brand Bone Chisel
Company Surgentec, LLC
Model SR99-6003
Published 2024-12-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810131880729 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 00810131880729 00810131880729 810131880729 0810131880729
GMDN Terms# Term, Definition table Term Definition Orthopaedic chisel A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004095409 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810131881061 BMAC Bevel Needle SR07-1500 AAN-11-BMACS 2025-01-03 00810131880941 BMAN Solid Diamond Needle SR07-1100 AAN-09-BMANS 2024-12-31 00810131880958 BMAN Solid Diamond Needle Kit SR07-1101 AAN-09-BMAN 2024-12-31 00810131880965 BMAN Solid Diamond Needle - Two Pack SR07-1102 AAN-09-2BMANS 2024-12-31 00810131880972 BMAN Solid Diamond Needle Kit - Two Pack SR07-1103 AAN-09-2BMAN 2024-12-31 00810131881009 BMAC Diamond Needle SR07-1300 AAN-09-BMACS 2024-12-31 00850040139587 "SI Guidewire 9""" SR16-5001 SI-P-GP 2024-08-16 00810131880583 Mallet - Large - Large Head SR99-6000 2024-12-10 00810131880590 Mallet - Large - Small Head SR99-6001 2024-12-10 00810131880606 "1/4"" Square Drill Chuck" SR99-6002 2024-12-10 00858406007181 OsteoFlo Synthetic NanoPutty Syringe- 1cc ONP-S-01 2020-11-19 00858406007198 OsteoFlo Synthetic NanoPutty Syringe- 2.5cc ONP-S-02 2020-11-19 00858406007204 OsteoFlo Synthetic NanoPutty Syringe- 510cc ONP-S-10 2020-11-19 00858406007211 OsteoFlo Synthetic NanoPutty Syringe- 5cc ONP-S-05 2020-11-19 00858406007228 OsteoFlo Synthetic NanoPutty Cartridge- 5cc ONP-T-500 2020-11-18 00858406007235 OsteoFlo Synthetic NanoPutty Cartridge- 10cc ONP-T-1000 2020-11-19 00081013188039 ION AO Coupling Cannulated Handle SR12-5006 2026-03-09 00810131880330 "T-Handle 3/16"" Connection" SR11-5002 2026-03-09 00810131881252 6.5/7.0 Drill Bit SR12-6442 2026-03-09 00810131881429 OsteoFlo HydroFiber - 1cc Labeled HF-OSF-01 2026-03-09
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