Catalog Number

-

Brand Name

MANTA

Version/Model Number

2115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MGB

Product Code Name

Device, Hemostasis, Vascular

Public Device Record Key

d5cc01de-0324-4a8f-a317-dff185b47297

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2019

Package DI Number

00856279007093

Quantity per Package

5

Contains DI Package

00856279007062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box