Dilator - Dilator - GALT MEDICAL CORP.

Duns Number:943156836

Device Description: Dilator

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


More Product Details

Catalog Number

DIL-615-52

Brand Name

Dilator

Version/Model Number

DIL-615-52

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

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

610c2a29-56aa-421c-ab80-240842c22ab3

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

August 09, 2017

Additional Identifiers

Package DI Number

20841268107049

Quantity per Package

100

Contains DI Package

10841268107042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"GALT MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 696