Catalog Number

2161-40000

Brand Name

Synchronis

Version/Model Number

2161-40000

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

9d4624ab-02ae-4396-a0b1-c824aa51978d

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Package DI Number

00850015884214

Quantity per Package

25

Contains DI Package

00850015884191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case