Twist Driver Kit TA500

GUDID 00850003396347

Twist 5.0mm Anchor on Driver.

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: 00850003396347
• NIH Device Record Key: 59fca0ce-cf69-44d0-b3d4-8e0c6afb0bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist Driver Kit
• Version Model Number: TA500
• Catalog Number: TA500
• 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	00850003396347 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

Ethylene Oxide

[00850003396347]

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

On-Brand Devices [Twist Driver Kit]

• 00850003396330: Twist 3.85mm Anchor on Driver.
• 00850003396347: Twist 5.0mm Anchor on Driver.