Catalog Number

PPD-AB650

Brand Name

Sharn Inc

Version/Model Number

PPD-AB650

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NOD

Product Code Name

BOARD, ARM (WTIH COVER), NON-STERILE

Public Device Record Key

d907f9a0-6415-4b59-b7a5-641fb1bc3c33

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

October 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-