ZipE Knotless Tissue Repair and Attachment Devices 64

GUDID 00858816006064

Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE braided suture, two thermoplastic tip covers

ZIPTEK LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00858816006064
• NIH Device Record Key: 1389db03-391f-469e-92eb-740a0729e58c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipE Knotless Tissue Repair and Attachment Devices
• Version Model Number: Rb41-S-4
• Catalog Number: 64
• 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	00858816006064 [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

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

• 00858816006064: Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capt
• 00858816006071: ZipE® resusable medical grade stainless steel punch tool