Zip E® Knotless Tissue Repair and Attachment Devices 61

GUDID 10858816006061

Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4, #4 resorbable captures/ca[ture holster, 2 #2 USP UHMWPE braided sutures, two thermoplastic tip covers per kit- 6 kits per shipper ( 10858816006061

ZIPTEK LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10858816006061
• NIH Device Record Key: c51b4c06-e6c6-407d-b952-ad5c20a810f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zip E® Knotless Tissue Repair and Attachment Devices
• Version Model Number: Rb41-S-4
• Catalog Number: 61
• 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	10858816006061 [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: 2024-06-11
• Device Publish Date: 2024-06-03

Devices Manufactured by ZIPTEK LLC

• 00858816006071 - ZipE Knotless Tissue Repair and attachment devices: 2024-07-29 ZipE® resusable medical grade stainless steel punch tool
• 00858816006088 - Ziptek knotless tissue repair and attachment devices: 2024-07-29 Ziptek small driver/handle assembly medical grade stainless steel for 4.5mm screw insertion and for pushing capture/button
• 00858816006101 - Ziptek knotless tissue repair and attachment devices: 2024-07-29 Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and b
• 00858816006064 - ZipE Knotless Tissue Repair and Attachment Devices: 2024-06-11 Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE bra
• 10858816006061 - Zip E® Knotless Tissue Repair and Attachment Devices: 2024-06-11Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4, #4 resorbable captures/ca[ture holster, 2 #2 USP UHMWPE braided sutures, two thermoplastic tip covers per kit- 6 kits per shipper ( 10858816006061
• 10858816006061 - Zip E® Knotless Tissue Repair and Attachment Devices: 2024-06-11 Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4, #4 resorbable captures/ca[ture holster, 2 #2 USP UHMWPE braided
• 10858816006009 - ZipE® Knotless Tissue Repair and Attachment Devices: 2019-06-12 ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided
• 10858816006016 - ZipE® Knotless Tissue Repair and Attachment Devices: 2019-06-12 ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided
• 10858816006023 - ZipE® Knotless Tissue Repair and Attachment Devices: 2019-06-12 ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and drive