Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

KM3405353-1

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

OGJ

Product Code Name

Nerve Block Tray

Public Device Record Key

10194e94-9f5c-4c9c-9bca-a205a9c3751b

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

20811870034927

Quantity per Package

10

Contains DI Package

00811870034923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA