Catalog Number

-

Brand Name

X-ray beam limiting device

Version/Model Number

BLR-15AA

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

K133553

Product Code

KPW

Product Code Name

Device, beam limiting, x-ray, diagnostic

Public Device Record Key

43aefa4a-bc33-40d0-b4f3-bc0d4edd6e6d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-