BLT-B - BARRIER LITE - BLACK- RADIATION PROTECTION GLASSES - BARRIER LITE - BLACK- RADIATION PROTECTION - Barrier Technologies, LLC

Duns Number:621134084

Device Description: BARRIER LITE - BLACK- RADIATION PROTECTION GLASSES

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More Product Details

Catalog Number

-

Brand Name

BLT-B - BARRIER LITE - BLACK- RADIATION PROTECTION GLASSES

Version/Model Number

BLT-B

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

IWS

Product Code Name

Shield, Eye, Radiological

Device Record Status

Public Device Record Key

df82906f-b2ca-4a32-9254-ef48f2628f73

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARRIER TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 107