HR Direct HM NSR Vit (VHRDHMNSRACS) - VOLK OPTICAL INC.

Duns Number:071125835

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More Product Details

Catalog Number

-

Brand Name

HR Direct HM NSR Vit (VHRDHMNSRACS)

Version/Model Number

VHRDHMNSRACS

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

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Device Record Status

Public Device Record Key

41b6822c-9dea-4fdb-8066-f63242877615

Public Version Date

September 30, 2020

Public Version Number

4

DI Record Publish Date

September 29, 2016

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