PreveLeak™ 10 pack Tips 8003

GUDID 00850868002056

Accessory tips for PreveLeak™ Surgical Sealant

Tenaxis Medical, Inc.

Surgical adhesive/sealant, animal-derived

• Primary Device ID: 00850868002056
• NIH Device Record Key: 002bd2fb-d421-4ac2-8f31-df32a25f9c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreveLeak™ 10 pack Tips
• Version Model Number: 10 pack Tips
• Catalog Number: 8003
• Company DUNS: 783546109
• Company Name: Tenaxis Medical, Inc.
• Device Count: 10
• 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: 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: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850868002056 [Primary]
GS1	00850868002070 [Unit of Use]

FDA Product Code

• NBE: Sealant,Polymerizing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-12-31

Devices Manufactured by Tenaxis Medical, Inc.

• 00850868002025 - PreveLeak™ Surgical Sealant: 2018-03-29 PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the c
• 00850868002032 - PreveLeak™ Surgical Sealant: 2018-03-29 PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the c
• 00850868002049 - PreveLeak™ Surgical Sealant: 2018-03-29 PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the c
• 00850868002056 - PreveLeak™ 10 pack Tips: 2018-03-29Accessory tips for PreveLeak™ Surgical Sealant
• 00850868002056 - PreveLeak™ 10 pack Tips: 2018-03-29 Accessory tips for PreveLeak™ Surgical Sealant
• 00850868002063 - PreveLeak™ Surgical Sealant: 2018-03-29 PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the c