Home GUDID 06938695508850 Bone Cement Injection Gun
Primary DI 06938695508850
Brand Bone Cement Injection Gun
Company Shanghai Kinetic Medical Co., Ltd.
Model SD8102
Catalog number SD8102
Device description Bone Cement Injection Gun
Published 2017-07-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KIH Dispenser, Cement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KIH Dispenser, Cement Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06938695508850 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06938695508850 06938695508850 6938695508850
GMDN Terms# Term, Definition table Term Definition Orthopaedic cement preparation/delivery kit A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 60 Centimeter Pressure 440 Pound per Square Inch
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 18 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 528198569 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06938695502155 Bone Drill FG2701 2025-12-09 06938695502254 Cannula FG2203 2025-12-09 06938695521026 Drill FG2100 2025-12-09 06938695527004 Bone Drill FG2700 2025-12-09 06938695522009 Cannula FG2200 FG2200 2016-12-05 06938695524003 Dilator FG2400 FG2400 2016-12-05 06938695530066 Puncture Needle FG3006 FG3006 2016-05-26 06938695537676 Dilator w/Cannula FG2410 FG2410 2020-05-31 06938695546067 KMC Guide Wire, 1.6mm, Blunt Tip KMC-000-00 2020-10-01 06938695546074 KMC Guide Wire, 1.6mm, Sharp Tip KMC-000-10 2020-10-01 06938695546081 KMC Access Needle, 11 Gauge, 95mm, Bevel Tip KMC-001-00 2020-10-01 06938695546098 KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip KMC-001-10 2020-10-01 06938695546104 KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip KMC-001-11 2020-10-01 06938695546111 KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond Tip KMC-001-20 2020-10-01 06938695546128 KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel Tip KMC-001-30 2020-10-01 06938695546135 KMC Access Needle, 13 Gauge, 95mm, Pyramid Tip KMC-002-00 2020-10-01 06938695546142 KMC Access Needle, 13 Gauge, 115mm, Pyramid Tip KMC-002-01 2020-10-01 06938695546159 KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel Tip KMC-002-10 2020-10-01 06938695546166 KMC Balloon Catheter, 8 Gauge, 10mm KMC-003-10 2020-10-01 06938695546173 KMC Balloon Catheter, 8 Gauge, 15mm KMC-003-15 2020-10-01
Other Devices Sharing Product Codes# 
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