Catalog Number

-

Brand Name

N/A

Version/Model Number

DMC217

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

-

Product Code Name

-

Public Device Record Key

1317aed3-ac76-4aed-a98b-9955e52cf6ab

Public Version Date

July 24, 2019

Public Version Number

1

DI Record Publish Date

July 16, 2019

Package DI Number

50884908143633

Quantity per Package

50

Contains DI Package

00884908143638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX