Catalog Number

CSTS-SA-000009

Brand Name

4WEB Medical

Version/Model Number

CSTS-SA-000009

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

-

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

HTW

Product Code Name

Bit, Drill

Public Device Record Key

69487dab-44aa-4af6-bdde-4b8aa11c8717

Public Version Date

October 29, 2020

Public Version Number

2

DI Record Publish Date

October 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-