BLOCKER - BLOCKER - Standard Size with Hook and Loop - BURLINGTON MEDICAL, LLC

Duns Number:083381202

Device Description: BLOCKER - Standard Size with Hook and Loop Closure, .35mm STRATA 300 Size 4, 18"L X 20"W

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More Product Details

Catalog Number

-

Brand Name

BLOCKER

Version/Model Number

S3BLOCKER4

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

IWO

Product Code Name

Apron, Protective

Device Record Status

Public Device Record Key

dbcf247c-2fe3-4f7d-9ff5-999428421233

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BURLINGTON MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12773
3 A medical device with high risk that requires premarket approval 1