Tridyne™ Vascular Sealant Extended Spray Tips TDET0006

GUDID 10801741099387

Tridyne Vascular Extended Tips, 6”

NEOMEND, INC.

General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 10801741099387
• NIH Device Record Key: 01ab6f2b-02a7-4998-8c69-ebe8416e97eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tridyne™ Vascular Sealant Extended Spray Tips
• Version Model Number: TDET0006
• Catalog Number: TDET0006
• Company DUNS: 195251595
• Company Name: NEOMEND, 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: true
• Device Kit: false
• Device Combination Product: true
• 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: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@crbard.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com
• Phone: +1(888)776-4351
• Email: medical.services@bd.com

Device Dimensions

• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
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• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
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• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
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• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
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• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
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• Length: 6 Inch
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• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741099380 [Primary]
GS1	10801741099387 [Package]; Contains: 00801741099380; Package: CA [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150016

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: 2019-11-08
• Device Publish Date: 2018-10-31

Devices Manufactured by NEOMEND, INC.

• 20801741010037 - Progel™ Applicator Spray Tips: 2019-11-08 Progel Applicator Spray Tips
• 20801741099377 - Tridyne™ Vascular Sealant Standard Spray Tips: 2019-11-08 Tridyne Vascular Sealant Standard Spray Tips
• 10801741010009 - Progel™Extended Applicator Spray Tip: 2019-11-08 Progel Extended Applicator Spray Tip
• 10801741010016 - Progel™Extended Applicator Spray Tip: 2019-11-08 Progel Extended Applicator Spray Tip
• 10801741099387 - Tridyne™ Vascular Sealant Extended Spray Tips: 2019-11-08Tridyne Vascular Extended Tips, 6”
• 10801741099387 - Tridyne™ Vascular Sealant Extended Spray Tips: 2019-11-08 Tridyne Vascular Extended Tips, 6”
• 10801741099363 - Tridyne™ Vascular Sealant: 2018-12-03 Tridyne Vascular Sealant
• 10801741010023 - Progel™ Pleural Air Leak Sealant: 2018-07-06 Progel Pleural Air Leak Sealant