Catalog Number

1915A

Brand Name

Palmero Healthcare, LLC

Version/Model Number

1915A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EGZ

Product Code Name

Holder, film, x-ray

Public Device Record Key

5ea3b7a5-572f-44f0-bede-ea43bcfa43ab

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-