Catalog Number

58

Brand Name

Palmero Healthcare

Version/Model Number

58

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

EKF

Product Code Name

Instrument, Contouring, Matrix, Operative

Public Device Record Key

3aaa86da-8cec-4719-a704-8f78af9e07c9

Public Version Date

July 22, 2021

Public Version Number

1

DI Record Publish Date

July 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-