Catalog Number

-

Brand Name

NAMIC

Version/Model Number

PK221607S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

db40b64f-2ada-4ad9-bc35-877246fa0296

Public Version Date

August 15, 2019

Public Version Number

1

DI Record Publish Date

August 07, 2019

Package DI Number

H965PK221607S1

Quantity per Package

10

Contains DI Package

H965PK221607S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX