ZipE® Knotless Tissue Repair and Attachment Devices

GUDID 10858816006009

ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6

ZIPTEK LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10858816006009
• NIH Device Record Key: da0cebd2-ba9d-4571-9b58-381408767be4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipE® Knotless Tissue Repair and Attachment Devices
• Version Model Number: RA6-6550-S
• Company DUNS: 035237962
• Company Name: ZIPTEK LLC
• 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	10858816006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162429

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: 2019-06-12
• Device Publish Date: 2019-06-04

On-Brand Devices [ZipE® Knotless Tissue Repair and Attachment Devices]

• 00858816006033: ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 reso
• 00858816006026: ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable captu
• 00858816006019: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm
• 00858816006002: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm
• 10858816006030: ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 reso
• 10858816006023: ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable captu
• 10858816006016: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm
• 10858816006009: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm