MANTA - 14F MANTA Vascular Closure Device - ESSENTIAL MEDICAL, INC.

Duns Number:013273872

Device Description: 14F MANTA Vascular Closure Device

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More Product Details

Catalog Number

-

Brand Name

MANTA

Version/Model Number

2156

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MGB

Product Code Name

Device, Hemostasis, Vascular

Device Record Status

Public Device Record Key

3e814640-c47e-482f-8c87-7345fc76cba5

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2019

Additional Identifiers

Package DI Number

00856279007109

Quantity per Package

5

Contains DI Package

00856279007079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box

"ESSENTIAL MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 2