GENESYS CrossFT, Hi-Fi CFBC-5503N

GUDID 30845854034600

GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 30845854034600
• NIH Device Record Key: 297b580a-b30a-4000-b0a5-1e480196aa49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESYS CrossFT, Hi-Fi
• Version Model Number: CFBC-5503N
• Catalog Number: CFBC-5503N
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• 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
• 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	10845854034606 [Previous]
GS1	20845854034603 [Primary]
GS1	30845854034600 [Package]; Contains: 20845854034603; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101100

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [GENESYS CrossFT, Hi-Fi]

• 30845854034617: GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30845854034600: GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30845854026810: 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
• 30845854026803: 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures
• 30845854026797: 5.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures