GENESYS PRESSFT, HI-FI NB211

GUDID 10845854027851

GENESYS PRESSFT 2.1 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10845854027851
• NIH Device Record Key: 63cba1bb-1421-4d47-abd7-058ba0511fda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESYS PRESSFT, HI-FI
• Version Model Number: NB211
• Catalog Number: NB211
• 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
• 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: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter
• Outer Diameter: 2.1 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854027851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121890

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-08-13
• Device Publish Date: 2015-10-24

On-Brand Devices [GENESYS PRESSFT, HI-FI]

• 30845854027893: GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 30845854027862: GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 10845854027905: GENESYS PRESSFT 2.6 W/TWO #1 (4 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)
• 10845854027882: GENESYS PRESSFT 2.6 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)
• 10845854027875: GENESYS PRESSFT 2.1 W/TWO #0 (3.5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)
• 10845854027851: GENESYS PRESSFT 2.1 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)