Catalog Number

-

Brand Name

Arm Drape

Version/Model Number

SYN-0788

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"

Yes

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

K850959,K850959

Product Code

JAA

Product Code Name

System, x-ray, fluoroscopic, image-intensified

Public Device Record Key

604fcd46-39b9-4a79-9352-52b4c9bcbdba

Public Version Date

June 05, 2020

Public Version Number

1

DI Record Publish Date

May 28, 2020

Package DI Number

10848340010573

Quantity per Package

10

Contains DI Package

00848340010576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-