MT - the balloon diameter is 10-11-12mm, the balloon - Micro-Tech (Nanjing) Co., Ltd.

Duns Number:530269083

Device Description: the balloon diameter is 10-11-12mm, the balloon length is 80mm, the catheter diameter is 6 the balloon diameter is 10-11-12mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter

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


More Product Details

Catalog Number

-

Brand Name

MT

Version/Model Number

FWB-10/80-6/18-M

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

-

Product Code Details

Product Code

KNQ

Product Code Name

Dilator, Esophageal

Device Record Status

Public Device Record Key

79e2ba4b-f282-4e4a-bd3f-4b670d4c5af5

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

16932503524039

Quantity per Package

10

Contains DI Package

06932503524032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"MICRO-TECH (NANJING) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 142