ELIMINATOR 000349

GUDID 00653405050926

8MM X 3CM PET BILIARY BALLOON DILATOR

Conmed Corporation

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 00653405050926
• NIH Device Record Key: e0e2fe23-d387-4aff-8be2-558f48c2cdec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELIMINATOR
• Version Model Number: 000349
• Catalog Number: 000349
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter
• Pressure: 120 Pound per Square Inch
• Outer Diameter: 8 Millimeter
• Length: 3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405050926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920361

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

[00653405050926]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [ELIMINATOR]

• 00653405050926: 8MM X 3CM PET BILIARY BALLOON DILATOR
• 00653405050919: 6MM X 2CM PET BILIARY BALLOON DILATOR
• 00653405050905: 4MM X 2CM PET BILIARY BALLOON DILATOR
• 10653405052623: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 20mm/60F, Multipack
• 10653405052616: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 18mm/54F, Multipack
• 10653405052609: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 15mm/45F, Multipack
• 10653405052593: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 12mm/36F, Multipack
• 20653405052583: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 20mm/60F
• 20653405052576: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 18mm/54F
• 20653405052569: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 15mm/45F
• 20653405052552: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 12mm/36F
• 20653405052545: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 10mm/30F
• 20653405052538: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 8mm/24F
• 20653405052521: CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET Balloon Dilator, 6mm/18F
• 10653405052517: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 20mm/60F, Multipack
• 10653405052500: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 18mm/54F, Multipack
• 10653405052494: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 15mm/45F, Multipack
• 10653405052487: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 12mm/36F, Multipack
• 20653405052477: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 20mm/60F
• 20653405052460: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 18mm/54F
• 20653405052453: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 15mm/45F
• 20653405052446: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 12mm/36F
• 20653405052439: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 10mm/30F
• 20653405052422: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 8mm/24F
• 20653405052415: CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 6mm/18F
• 20653405050916: 6MM X 2CM PET BILIARY BALLOON DILATOR
• 20653405050923: 8MM X 3CM PET BILIARY BALLOON DILATOR