Catalog Number

-

Brand Name

CUSTOM HEALTHCARE SYSTEMS, INC

Version/Model Number

B9-19630

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

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

9f0e617e-8664-4258-bdf0-9134e6624f82

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Package DI Number

20811870034194

Quantity per Package

50

Contains DI Package

00811870034190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A