Catalog Number

-

Brand Name

NA

Version/Model Number

CG8901

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

K050044,K050044

Product Code

HBO

Product Code Name

CLIP, SCALP

Public Device Record Key

8ba5c28d-78b8-45d9-b577-7a6fed5eabe3

Public Version Date

March 14, 2019

Public Version Number

4

DI Record Publish Date

August 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-