Kopis Knotless Anchor

GUDID 10818614022540

Kopis 6.5mm Knotless Anchor, Peek

Maruho Medical, Inc.

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: 10818614022540
• NIH Device Record Key: 2b46d80a-e812-4f45-bd31-93d9716649de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kopis Knotless Anchor
• Version Model Number: F-31-16520
• Company DUNS: 117630237
• Company Name: Maruho Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00818614022543 [Primary]
GS1	10818614022540 [Package]; Contains: 00818614022543; Package: Box [5 Units]; In Commercial Distribution

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: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [Kopis Knotless Anchor]

• 10818614022540: Kopis 6.5mm Knotless Anchor, Peek
• 10818614022533: Kopis 5.5mm Knotless Anchor, Peek
• 10818614022526: Kopis 4.5mm Knotless Anchor, Peek