Home GUDID 20653405053351 SINGULAR
Primary DI 20653405053351
Brand SINGULAR
Company Conmed Corporation
Model 000988
Catalog number 000988
Device description SINGULAR Polypectomy Snare; X-Small Oval Loop, Soft Wire, Microvasive Connector
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FDI SNARE, FLEXIBLE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDI Snare, Flexible Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20653405053351 Package GS1 10 Not in Commercial Distribution 10653405053354 Primary GS1 0 00653405053357 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20653405053351 20653405053351 10653405053354 10653405053354 00653405053357 00653405053357 653405053357 0653405053357
GMDN Terms# Term, Definition table Term Definition Endoscopic electrosurgical electrode, monopolar, single-use A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 230 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 85 Percent (%) Relative Humidity Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature -29 Degrees Celsius 60 Degrees Celsius Handling Environment Temperature -20 Degrees Fahrenheit 140 Degrees Fahrenheit Handling Environment Temperature 16 Degrees Celsius 27 Degrees Celsius Handling Environment Temperature 60 Degrees Fahrenheit 80 Degrees Fahrenheit Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 32 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 90 Degrees Fahrenheit
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 071595540 Device count 10 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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# 
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