Miti 10433

GUDID 00816342021357

2.5mm Miti Suture Anchor w/ One #2 Suture with Needles

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: 00816342021357
• NIH Device Record Key: d2ecd80d-af5d-4712-bd14-6a77b7bc923f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miti
• Version Model Number: 10433
• Catalog Number: 10433
• 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 Dimensions

• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342021357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111000

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

On-Brand Devices [Miti]

• 00816342021395: 3.5mm Miti Suture Anchor w/ One #2 Suture with Needles
• 00816342021364: 2.5mm Miti Suture Anchor w/ One #2 Suture
• 00816342021357: 2.5mm Miti Suture Anchor w/ One #2 Suture with Needles
• 00816342021340: 2.0mm Miti Suture Anchor w/ Two 3-0 Sutures with Needles