Progel™Extended Applicator Spray Tip PGEN005-11

GUDID 10801741010016

Progel Extended Applicator Spray Tip

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

• Primary Device ID: 10801741010016
• NIH Device Record Key: 5dcb9ca9-7b8e-4bc8-926e-bf3121ee244a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Progel™Extended Applicator Spray Tip
• Version Model Number: PGEN005-11
• Catalog Number: PGEN005-11
• 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: 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@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

• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741010019 [Primary]
GS1	10801741010016 [Package]; Contains: 00801741010019; Package: CA [4 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

On-Brand Devices [Progel™Extended Applicator Spray Tip]

• 10801741010016: Progel Extended Applicator Spray Tip
• 10801741010009: Progel Extended Applicator Spray Tip