Pan Retinal 2.2 Clear, Gold Ring - VOLK OPTICAL INC.

Duns Number:071125835

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Pan Retinal 2.2 Clear, Gold Ring

Version/Model Number

VPRC-GD

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

HJL

Product Code Name

Lens, Condensing, Diagnostic

Device Record Status

Public Device Record Key

042954a9-893e-4da1-9e19-0a90746768a0

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VOLK OPTICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 168
2 A medical device with a moderate to high risk that requires special controls. 92