Twist Kit

GUDID 00850003396323

Flexband 30cm device with anchors and instruments kit

Artelon

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: 00850003396323
• NIH Device Record Key: a99b2699-5b54-4464-9689-f334af0d8fcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist Kit
• Version Model Number: TW030
• Company DUNS: 066284070
• Company Name: Artelon
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tiffini.wittwer@artelon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003396323 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

[00850003396323]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by Artelon

• 00850003396248 - Twist Kit: 2024-04-19 Flexband 12cm device with anchors and instruments kit
• 00850003396323 - Twist Kit: 2024-04-19Flexband 30cm device with anchors and instruments kit
• 00850003396323 - Twist Kit: 2024-04-19 Flexband 30cm device with anchors and instruments kit
• 00850003396347 - Twist Driver Kit: 2024-04-19 Twist 5.0mm Anchor on Driver.
• 00850003396330 - Twist Driver Kit: 2024-04-18 Twist 3.85mm Anchor on Driver.
• 00850003396187 - FlexBand Plus: 2023-06-01 FlexBand Plus 0.5 x 24 Strip with Suture
• 00850003396200 - DRILL BIT AND GUIDE: 2023-06-01 Cannulated Drill Bit and Guide
• 10850003396214 - FLEXBAND FIX: 2023-06-01 FLEXBAND and anchor kit with paddle handle
• 00850003396255 - FlexBand Eyelet Anchor: 2023-06-01 Hex Eyelet Anchor