MMS - Rectal balloon catheter with introducer - MEDIPLUS LTD

Duns Number:228480810

Device Description: Rectal balloon catheter with introducer

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MMS

Version/Model Number

MMS5415i

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)

Yes

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

KGZ

Product Code Name

ACCESSORIES, CATHETER

Device Record Status

Public Device Record Key

375eb243-bd3c-4e52-aff5-e31da897d7a7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

15055140703153

Quantity per Package

25

Contains DI Package

05055140703156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDIPLUS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 95