Catalog Number

IS034-DL

Brand Name

I-View Silver

Version/Model Number

Size 1

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"

-

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

K210312

Product Code

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Public Device Record Key

b1aeef02-322f-4f49-8c97-e431b295abf1

Public Version Date

March 10, 2022

Public Version Number

1

DI Record Publish Date

March 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-