MANTA 14F Depth Locator

GUDID 00856279007215

ESSENTIAL MEDICAL, INC.

Femoral artery closure plug/patch, collagen
Primary Device ID00856279007215
NIH Device Record Keybd9464dc-9f3b-418e-b9b5-2805981e870e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANTA 14F Depth Locator
Version Model Number114F
Company DUNS013273872
Company NameESSENTIAL MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com
Phone866-246-6990
Emailcs@teleflex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856279007208 [Primary]
GS100856279007215 [Package]
Contains: 00856279007208
Package: [5 Units]
In Commercial Distribution

FDA Product Code

MGBDevice, Hemostasis, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

Devices Manufactured by ESSENTIAL MEDICAL, INC.

10856279007304 - MANTA2023-10-31 18F MANTA Vascular Closure Device
10856279007328 - MANTA2023-10-31 14F MANTA Vascular Closure Device
10856279007342 - MANTA2023-10-31 MANTA 8F Depth Locator
10856279007366 - MANTA2023-10-31 MANTA 14F Depth Locator
00856279007215 - MANTA 14F Depth Locator2021-07-08
00856279007215 - MANTA 14F Depth Locator2021-07-08
00856279007246 - MANTA 8F Depth Locator2020-10-26
00856279007062 - MANTA2019-03-11 18F MANTA Vascular Closure Device
00856279007079 - MANTA2019-03-11 14F MANTA Vascular Closure Device

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.