Catalog Number

96101-60

Brand Name

NvisionVLE Inflation Kit

Version/Model Number

96101-60

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"

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

K143678,K143678

Product Code

NQQ

Product Code Name

System, Imaging, Optical Coherence Tomography (Oct)

Public Device Record Key

a1983968-e861-47b7-a17c-202b54d02b55

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

10859591006239

Quantity per Package

5

Contains DI Package

00859591006232

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-