Catalog Number

GWI1802EUS

Brand Name

Manan Medical Products, Inc.

Version/Model Number

GWI1802EUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 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

83126196-8a2b-4919-b159-0194fcbd137f

Public Version Date

July 19, 2021

Public Version Number

4

DI Record Publish Date

October 26, 2016

Package DI Number

20859013006165

Quantity per Package

10

Contains DI Package

10859013006168

Package Discontinue Date

March 02, 2019

Package Status

Not in Commercial Distribution

Package Type

Unit Boxes