Tridyne™ Vascular Sealant TDVS004

GUDID 10801741099363

Tridyne Vascular Sealant

NEOMEND, INC.

Surgical adhesive/sealant, human-derived Surgical adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived Surgical internal adhesive/sealant, human-derived

• Primary Device ID: 10801741099363
• NIH Device Record Key: 5d81d919-c4a7-4937-8ba8-9fad157e6221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tridyne™ Vascular Sealant
• Version Model Number: TDVS004
• Catalog Number: TDVS004
• 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@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

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741099366 [Primary]
GS1	10801741099363 [Package]; Contains: 00801741099366; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• 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: 2019-11-08 Tridyne Vascular Extended Tips, 6”
• 10801741099363 - Tridyne™ Vascular Sealant: 2018-12-03Tridyne Vascular Sealant
• 10801741099363 - Tridyne™ Vascular Sealant: 2018-12-03 Tridyne Vascular Sealant
• 10801741010023 - Progel™ Pleural Air Leak Sealant: 2018-07-06 Progel Pleural Air Leak Sealant