Catalog Number

SMA4AVSYNA

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA4AVSYNA

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEC

Product Code Name

BRUSH, SCRUB, OPERATING-ROOM

Public Device Record Key

87a4f052-a2a7-4889-803e-93cb78343ec3

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

June 27, 2016

Package DI Number

50887488385738

Quantity per Package

35

Contains DI Package

10887488385730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE