Biocomposite Suture Anchors

GUDID 00816342025157

4.5mm Twist Biocomposite Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00816342025157
• NIH Device Record Key: c2bcd191-550d-483e-bb36-f323a07e9924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocomposite Suture Anchors
• Version Model Number: 11125T
• 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	00816342025157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183501

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, 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: 2023-08-07
• Device Publish Date: 2023-07-30

On-Brand Devices [Biocomposite Suture Anchors]

• 00816342025232: 4.5mm Twist Biocomposite SST Suture Anchor
• 00816342025225: 4.5mm Twist Biocomposite SST Suture Anchor
• 00816342025157: 4.5mm Twist Biocomposite Suture Anchor
• 00816342024822: 55 Knotless AP Suture Anchor
• 00816342024815: 45 Knotless AP Suture Anchor
• 00816342024808: 28 Knotless AP Suture Anchor