MANTA 8F Depth Locator

GUDID 00856279007246

ESSENTIAL MEDICAL, INC.

Femoral artery closure plug/patch, collagen
Primary Device ID00856279007246
NIH Device Record Keybce95fb1-2462-46d7-bba2-425992d07e01
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANTA 8F Depth Locator
Version Model Number188F
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856279007246 [Primary]

FDA Product Code

MGBDevice, Hemostasis, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-10-26
Device Publish Date2020-05-21

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
00856279007246 - MANTA 8F Depth Locator2020-10-26
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

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