Catalog Number

1850S

Brand Name

Palmero Healthcare, LLC

Version/Model Number

1850S

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

NRU

Product Code Name

CHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Public Device Record Key

862d1606-e544-450c-bd4c-552a89d951a9

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-