MANTA

GUDID 00856279007079

14F MANTA Vascular Closure Device

ESSENTIAL MEDICAL, INC.

Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen

• Primary Device ID: 00856279007079
• NIH Device Record Key: 3e814640-c47e-482f-8c87-7345fc76cba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANTA
• Version Model Number: 2156
• Company DUNS: 013273872
• Company Name: ESSENTIAL MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com
• Phone: 866-246-6990
• Email: cs@teleflex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856279007079 [Primary]
GS1	00856279007109 [Package]; Package: Shelf Box [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: 2019-03-11
• Device Publish Date: 2019-02-08

On-Brand Devices [MANTA]

• 00856279007079: 14F MANTA Vascular Closure Device
• 00856279007062: 18F MANTA Vascular Closure Device
• 10856279007366: MANTA 14F Depth Locator
• 10856279007342: MANTA 8F Depth Locator
• 10856279007328: 14F MANTA Vascular Closure Device
• 10856279007304: 18F MANTA Vascular Closure Device