Catalog Number

502652

Brand Name

Manan Medical Products, Inc.

Version/Model Number

502652

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2019

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

K851834,K851834,K851834

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

f6233f12-7f3b-4ad2-af74-1418a3432d4d

Public Version Date

July 19, 2021

Public Version Number

4

DI Record Publish Date

October 26, 2016

Package DI Number

20859013006158

Quantity per Package

3

Contains DI Package

10859013006151

Package Discontinue Date

March 11, 2019

Package Status

Not in Commercial Distribution

Package Type

Unit Boxes