SaberX Radianz - SABERX RADIANZ 3.5MM8CM 190 - CORDIS CORPORATION

Duns Number:806136177

Device Description: SABERX RADIANZ 3.5MM8CM 190

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More Product Details

Catalog Number

R51003508L

Brand Name

SaberX Radianz

Version/Model Number

R51003508L

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

K201377

Product Code Details

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Device Record Status

Public Device Record Key

d98aa1f0-97d2-45e5-bd03-e8ba3a20d8a3

Public Version Date

September 14, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORDIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2567
3 A medical device with high risk that requires premarket approval 204