PROFORMA 050330

GUDID 10653405051251

PROFORMA Cannula, Short Tapered Tip, Pre-Curved

Conmed Corporation

Cholangiopancreatography catheter, single-use Cholangiopancreatography catheter, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use

• Primary Device ID: 10653405051251
• NIH Device Record Key: 94eb1287-7ec1-4113-8982-11b70d175985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFORMA
• Version Model Number: 050330
• Catalog Number: 050330
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 3
• 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

Device Dimensions

• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter
• Length: 200 Centimeter
• Catheter Gauge: 5 French
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Outer Diameter: 0.89 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405051254 [Unit of Use]
GS1	10653405051251 [Package]; Contains: 20653405051258; Package: BOX [3 Units]; In Commercial Distribution
GS1	20653405051258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950700

FDA Product Code

• ODD: Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

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

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

Ethylene Oxide

[10653405051251]

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: 2016-09-24

On-Brand Devices [PROFORMA]

• 50653405051419: PROFORMA HF 4.5 Cannula, Straight Taper Tip
• 10653405055419: PROFORMA Cannula, Long Tapered Tip, Straight
• 10653405051411: PROFORMA HF 4.5 Cannula, Straight Taper Tip
• 10653405051299: PROFORMA Cannula, Short Tapered Tip, Straight
• 10653405051275: PROFORMA Cannula, Standard Tip, Straight
• 10653405051268: PROFORMA Cannula, Metal Ball, Pre-Curved
• 10653405051251: PROFORMA Cannula, Short Tapered Tip, Pre-Curved
• 10653405051244: PROFORMA Cannula, Long Tapered Tip, Pre-Curved
• 10653405051237: PROFORMA Cannula, Standard Tip, Pre-Curved