WomanCare Global Uterine Evacuation Kit - Each kit contains one Ipas Double-Valve - WOMANCARE GLOBAL TRADING, INC.

Duns Number:064730456

Device Description: Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae : 6mm, 7mm, 8 Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae : 6mm, 7mm, 8mm and 9 mm, 3 Denniston Dilators: 5/6mm, 7/8mm and 9/10 mm.

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More Product Details

Catalog Number

-

Brand Name

WomanCare Global Uterine Evacuation Kit

Version/Model Number

UEK-SU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

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

HHI

Product Code Name

System, Abortion, Vacuum

Device Record Status

Public Device Record Key

e3046d4b-11ea-4940-8c91-3406a6b3a07f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WOMANCARE GLOBAL TRADING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34