MANTA 14F Depth Locator

GUDID 00856279007215

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

• Primary Device ID: 00856279007215
• NIH Device Record Key: bd9464dc-9f3b-418e-b9b5-2805981e870e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANTA 14F Depth Locator
• Version Model Number: 114F
• Company DUNS: 013273872
• Company Name: ESSENTIAL MEDICAL, 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: 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	00856279007208 [Primary]
GS1	00856279007215 [Package]; Contains: 00856279007208; Package: [5 Units]; In Commercial Distribution

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: 2021-07-08
• Device Publish Date: 2021-06-30

Devices Manufactured by ESSENTIAL MEDICAL, INC.

• 10856279007304 - MANTA: 2023-10-31 18F MANTA Vascular Closure Device
• 10856279007328 - MANTA: 2023-10-31 14F MANTA Vascular Closure Device
• 10856279007342 - MANTA: 2023-10-31 MANTA 8F Depth Locator
• 10856279007366 - MANTA: 2023-10-31 MANTA 14F Depth Locator
• 00856279007215 - MANTA 14F Depth Locator: 2021-07-08
• 00856279007215 - MANTA 14F Depth Locator: 2021-07-08
• 00856279007246 - MANTA 8F Depth Locator: 2020-10-26
• 00856279007062 - MANTA: 2019-03-11 18F MANTA Vascular Closure Device
• 00856279007079 - MANTA: 2019-03-11 14F MANTA Vascular Closure Device