Catalog Number

ISC-T-1200

Brand Name

Mawi DNA Technologies

Version/Model Number

ISC-T-1200

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"

-

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

JJH

Product Code Name

Clinical Sample Concentrator

Public Device Record Key

32600c27-3c91-4ae9-846b-4100e2e38235

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Package DI Number

10850040712152

Quantity per Package

50

Contains DI Package

00850040712155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Rack