Progel™ Applicator Spray Tips PGST009

GUDID 20801741010037

Progel Applicator Spray Tips

NEOMEND, INC.

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

• Primary Device ID: 20801741010037
• NIH Device Record Key: 9c0e7abe-5e95-4190-930d-2924c7fe98eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Progel™ Applicator Spray Tips
• Version Model Number: PGST009
• Catalog Number: PGST009
• Company DUNS: 195251595
• Company Name: NEOMEND, INC.
• Device Count: 2
• 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: +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 Identifiers

Device Issuing Agency	Device ID
GS1	00801741010033 [Unit of Use]
GS1	10801741010030 [Primary]
GS1	20801741010037 [Package]; Contains: 10801741010030; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010047

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2014-09-12

Devices Manufactured by NEOMEND, INC.

• 20801741010037 - Progel™ Applicator Spray Tips: 2019-11-08Progel Applicator Spray Tips
• 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: 2018-12-03 Tridyne Vascular Sealant
• 10801741010023 - Progel™ Pleural Air Leak Sealant: 2018-07-06 Progel Pleural Air Leak Sealant