Synd-EZ 11223

GUDID 00816342024402

Synd-EZ Ti

PARCUS MEDICAL LLC

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 Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342024402
• NIH Device Record Key: 653986a6-4d41-4d3c-8fd9-8102fcacc85c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synd-EZ
• Version Model Number: 11223
• Catalog Number: 11223
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342024402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191783

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2021-12-17
• Device Publish Date: 2021-12-09

On-Brand Devices [Synd-EZ]

• M685112240: Synd-EZ SS
• M685112230: Synd-EZ Ti
• 00816342024402: Synd-EZ Ti