Dornier MedTech - Cascade Ureteral Stent, 7Fr x 26cm - DORNIER MEDTECH AMERICA, INC.

Duns Number:130789944

Device Description: Cascade Ureteral Stent, 7Fr x 26cm

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More Product Details

Catalog Number

CAS7026

Brand Name

Dornier MedTech

Version/Model Number

Cascade Ureteral Stent, 7Fr x 26cm

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

FAD

Product Code Name

Stent, Ureteral

Device Record Status

Public Device Record Key

5bf64cfe-e4e6-4ccf-8630-450a78cb29d3

Public Version Date

March 04, 2020

Public Version Number

1

DI Record Publish Date

February 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DORNIER MEDTECH AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 101