VISTA BRITE TIP - GC 7F 078 XB 4.5 - CORDIS CORPORATION

Duns Number:806136177

Device Description: GC 7F 078 XB 4.5

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More Product Details

Catalog Number

77805800

Brand Name

VISTA BRITE TIP

Version/Model Number

77805800

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

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Device Record Status

Public Device Record Key

865d3c1a-fc3e-4448-9dd9-383d6551b257

Public Version Date

September 14, 2022

Public Version Number

10

DI Record Publish Date

September 18, 2017

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