Draw Tight Suture Anchor

GUDID 00816342021555

Draw Tight 3.2mm Single Loaded

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342021555
• NIH Device Record Key: ce9046d6-1047-4e56-97bd-046e78f5b078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Draw Tight Suture Anchor
• Version Model Number: 10566
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342021555 [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: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [Draw Tight Suture Anchor]

• 00816342021975: Draw Tight 3.2mm Double Loaded
• 00816342021555: Draw Tight 3.2mm Single Loaded
• 00816342024389: Draw Tight 3.2mm w/2, 1.6mm Suture Tape
• 00816342024372: Draw Tight 3.2mm w/2, 1.6mm Suture Tape
• 00816342024112: 3.2mm Draw Tight, push-in, suture anchor, w/2, 1.6mm suture tape (wht/blu & wht/blk)
• 00816342024105: 1.8mm Draw Tight, push-in, suture anchor, w/1, 1.6mm suture tape (wht/blu)