Palmero Healthcare, LLC - DISPOS-A-SCREENS (100) (100) - Palmero Healthcare LLC

Duns Number:080530675

Device Description: DISPOS-A-SCREENS (100) (100)

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More Product Details

Catalog Number

1602B

Brand Name

Palmero Healthcare, LLC

Version/Model Number

1602B

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

Yes

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

DYN

Product Code Name

Mouthpiece, saliva ejector

Device Record Status

Public Device Record Key

8bb52098-1635-43a5-8a2d-7f9d6f68b06d

Public Version Date

February 10, 2021

Public Version Number

1

DI Record Publish Date

February 02, 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