Twist Knotless DEX 11260

GUDID M685112600

5.5 x 15 Twist Knotless DEX Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M685112600
• NIH Device Record Key: 4403e805-031c-4038-a117-fea7559ea5b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist Knotless DEX
• Version Model Number: 11260
• Catalog Number: 11260
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• 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: 941-755-7965
• Email: CustomerService@ParcusMedical.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M685112600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170327

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: 2019-10-31
• Device Publish Date: 2019-10-23

On-Brand Devices [Twist Knotless DEX]

• M685112610: 6.25 x 15 Twist Knotless DEX Suture Anchor
• M685112600: 5.5 x 15 Twist Knotless DEX Suture Anchor
• M685112590: 4.75 x 15 Twist Knotless DEX Suture Anchor