NA - Balloon catheter with an insertion sheathfor - C R I

Duns Number:130814890

Device Description: Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfo Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media

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More Product Details

Catalog Number

VMI1187

Brand Name

NA

Version/Model Number

7F Shapeable HS Catheter

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"

Yes

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

K032835,K032835

Product Code Details

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Device Record Status

Public Device Record Key

21c26f0c-9b1f-4d3e-a2a6-d33432e03620

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

10852073002071

Quantity per Package

10

Contains DI Package

00852073002074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"C R I" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 46