UNIVERSAL PLUS/FLOVAC 60-6001-105

GUDID 20653405011405

UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITHOUT SIDE HOLES, CANNULA 10MM X 32CM

Conmed Corporation

Rigid endoscopic cannula, single-use

• Primary Device ID: 20653405011405
• NIH Device Record Key: 7b1d20a5-dbb3-444c-9f53-f36d748f111a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL PLUS/FLOVAC
• Version Model Number: 60-6001-105
• Catalog Number: 60-6001-105
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 5
• 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

• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 32 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405011401 [Unit of Use]
GS1	20653405011405 [Package]; Contains: 30653405011402; Package: BOX [5 Units]; In Commercial Distribution
GS1	30653405011402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960562

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

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 [UNIVERSAL PLUS/FLOVAC]

• 20653405031502: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 10MM X 32CM
• 20653405011481: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH LASER ACCESS,CANNULA 5MM X 32CM
• 20653405011474: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5MM X 44CM
• 20653405011450: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITH SIDE HOLES, CANNULA 5MM X 32CM
• 20653405011405: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITHOUT SIDE HOLES, CANNULA 10MM X 32CM
• 20653405011368: UNIVERSAL PLUS/FLOVAC, SOFT-TIP SUMP CANNULA, CANNULA 10MM X 32MM