Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

B9-18946

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

d2e242ed-e4e0-4be1-b2bd-22b6e4554ddd

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

July 27, 2018

Package DI Number

20811870035795

Quantity per Package

25

Contains DI Package

00811870035791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A