Catalog Number

-

Brand Name

MANTA 14F Depth Locator

Version/Model Number

114F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

bd9464dc-9f3b-418e-b9b5-2805981e870e

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

00856279007215

Quantity per Package

5

Contains DI Package

00856279007208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-