Volk Vold Surgical Gonio Lens - VOLK OPTICAL INC.

Duns Number:071125835

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More Product Details

Catalog Number

-

Brand Name

Volk Vold Surgical Gonio Lens

Version/Model Number

VTSVVG

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

HKS

Product Code Name

Prism, Gonioscopic

Device Record Status

Public Device Record Key

9a01921c-118d-4b8c-8d27-311f829b37c9

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 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