Palmero Healthcare, LLC - PAN-A-CAPE APRON BLUE - Palmero Healthcare LLC

Duns Number:080530675

Device Description: PAN-A-CAPE APRON BLUE

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More Product Details

Catalog Number

29BLUE

Brand Name

Palmero Healthcare, LLC

Version/Model Number

29BLUE

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

EAJ

Product Code Name

Apron, leaded

Device Record Status

Public Device Record Key

bfe7f887-9111-41a3-8165-28db65cffd70

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PALMERO HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 740