Catalog Number

PG-STR-S2510

Brand Name

PlastCare

Version/Model Number

PG-STR-S2510

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

FRK

Product Code Name

Chair, Examination And Treatment

Public Device Record Key

63df22ee-ace7-4ba4-aa09-e75bd71e8a11

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

D066PGSTRS25102

Quantity per Package

36

Contains DI Package

D066PGSTRS25101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-