Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

ZZ-0666

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

-

Product Code

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

27f6aa90-899f-4f1d-87d5-69bbfe97f33a

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Package DI Number

20811870034781

Quantity per Package

48

Contains DI Package

00811870034787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA