Draw Tight 10565

GUDID M685105650

Draw Tight 1.8mm Single Loaded

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M685105650
• NIH Device Record Key: 6751a5c1-8762-4654-bcbd-29f7e25a2fb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Draw Tight
• Version Model Number: 10565
• Catalog Number: 10565
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M685105650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122805

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: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Draw Tight]

• M685105880: Draw Tight 3.2mm Double Loaded
• M685105650: Draw Tight 1.8mm Single Loaded
• M685112970: 1.8mm Draw Tight Suture Anchor with One Suture Tape
• M685112890: 3.2mm Draw Tight Suture Anchor with Two Suture Tapes
• M685112880: 3.2mm Draw Tight Suture Anchor with Two Suture Tapes
• 00816342024099: Draw Tight DEX Suture Anchor w/1 1.6mm Suture Tape with Needles
• 00816342021562: Draw Tight 3.2mm Double Loaded
• 00816342021548: Draw Tight 1.8mm Single Loaded