Argo Knotless GENESYS KBC55TW

GUDID 30653405988667

5.5mm Argo Knotless® GENESYSTM Anchor, HI-FI Tape, White/Black

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 30653405988667
• NIH Device Record Key: 83fe0e0e-cb23-42e0-89ba-9d35d0745b91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argo Knotless GENESYS
• Version Model Number: KBC55TW
• Catalog Number: KBC55TW
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE

Device Identifiers

Device Issuing Agency	Device ID
GS1	20653405988660 [Primary]
GS1	30653405988667 [Package]; Contains: 20653405988660; Package: CARTON [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240090

FDA Product Code

• MBI: Fastener, fixation, nondegradable, 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: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [Argo Knotless GENESYS]

• 10653405988601: 4.75 mm Argo KnotlessTM GENESYSTM Reusable Smooth Punch
• 10653405988595: 5.5 mm Argo KnotlessTM GENESYSTM Reusable Tap
• 10653405988588: 4.75 mm Argo KnotlessTM GENESYSTM Reusable Tap
• 10653405988571: 4.75/5.5 mm Argo KnotlessTM GENESYSTM Reusable Broaching Punch
• 30653405988766: 4.75/5.5 mm Argo KnotlessTM GENESYSTM Disposable Broaching Punch
• 30653405988759: 4.75 mm Argo KnotlessTM GENESYSTM Disposable Smooth Punch
• 30653405988742: 4.75 mm Argo KnotlessTM GENESYSTM Disposable Tap
• 30653405988735: 5.5 mm Argo KnotlessTM GENESYSTM Disposable Tap
• 30653405988698: 4.75mm Argo Knotless® GENESYSTM Anchor, HI-FI Tape, White/Black
• 30653405988681: 4.75mm Argo Knotless® GENESYSTM Anchor, HI-FI Tape, Blue/Blue
• 30653405988674: 4.75mm Argo Knotless® GENESYSTM Anchor
• 30653405988667: 5.5mm Argo Knotless® GENESYSTM Anchor, HI-FI Tape, White/Black
• 30653405988650: 5.5mm Argo Knotless® GENESYSTM Anchor, HI-FI Tape, Blue/Blue
• 30653405988643: 5.5mm Argo Knotless® GENESYSTM Anchor