Catalog Number

-

Brand Name

ApolloVue S100 Image System

Version/Model Number

S100-000US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

NQQ

Product Code Name

System, Imaging, Optical Coherence Tomography (Oct)

Public Device Record Key

646dfd4e-01a8-4e2b-835b-b74e1990d390

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

October 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-