Catalog Number

-

Brand Name

N/A

Version/Model Number

CL8903

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

db2f8561-d0c8-4b23-9f05-7a20d0e4d27f

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-