57525338

GUDID 20845854061388

Reducer fitting 22mm to 6.5mm

Conmed Corporation

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Primary Device ID20845854061388
NIH Device Record Key9b3f1f54-325d-49a0-8972-b65283ec8ed0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number57525338
Catalog Number57525338
Company DUNS071595540
Company NameConmed Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120845854061388 [Primary]

FDA Product Code

GAZTUBING, NONINVASIVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

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30845854026803 - GENESYS CrossFT, Hi-Fi2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures
30845854026810 - GENESYS CrossFT, Hi-Fi2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
30845854027862 - GENESYS PressFT, Hi-Fi2024-04-25 GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
30845854027893 - GENESYS PressFT, Hi-Fi2024-04-25 GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
30845854034600 - GENESYS CrossFT, Hi-Fi2024-04-25 GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
30845854034617 - GENESYS CrossFT, Hi-Fi2024-04-25 GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
30653405988643 - Argo Knotless GENESYS2024-04-22 5.5mm Argo Knotless® GENESYSTM Anchor

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