MANTA 2115

GUDID 20841156109926

18F MANTA Vascular Closure Device

TELEFLEX INCORPORATED

Femoral artery closure plug/patch, collagen

• Primary Device ID: 20841156109926
• NIH Device Record Key: 6cede201-9248-4dc7-a27e-5a77ac11ea36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANTA
• Version Model Number: IPN923493
• Catalog Number: 2115
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight
• Storage Environment Temperature: Between 15 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunglight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156109929 [Primary]
GS1	20841156109926 [Package]; Contains: 10841156109929; Package: Pouch [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180025

FDA Product Code

• MGB: Device, hemostasis, vascular

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: 2024-09-17
• Device Publish Date: 2024-09-09

On-Brand Devices [MANTA]

• 20841156109957: MANTA 14F Depth Locator
• 20841156109933: MANTA 8F Depth Locator
• 20841156109926: 18F MANTA Vascular Closure Device
• 20841156109902: 14F MANTA Vascular Closure Device