Catalog Number

-

Brand Name

Innervision, BioGlide®

Version/Model Number

99102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983331

Product Code

HCA

Product Code Name

CATHETER, VENTRICULAR

Public Device Record Key

506d4069-11f3-4810-985c-206f78975860

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-