Catalog Number

-

Brand Name

R-20J

Version/Model Number

563-55050-50

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101036

Product Code

IZX

Product Code Name

Collimator, Manual, Radiographic

Public Device Record Key

fafee4de-9b3b-4ee6-9e9d-20aa1f110d4d

Public Version Date

March 02, 2020

Public Version Number

1

DI Record Publish Date

February 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-