BLANKET - RCCPB-OS (BLANKET, .5MM COST CRUNCHER, PROTECTIVE - BURLINGTON MEDICAL, LLC

Duns Number:083381202

Device Description: RCCPB-OS (BLANKET, .5MM COST CRUNCHER, PROTECTIVE BLANKET, 24" X 48")

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More Product Details

Catalog Number

-

Brand Name

BLANKET

Version/Model Number

RCCPB-OS

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

KPY

Product Code Name

Shield, Protective, Personnel

Device Record Status

Public Device Record Key

6e8b0dbc-19a3-40b9-8cb6-db89b8275cd4

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 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