Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

BMTX-1047

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"

Yes

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

DWO

Product Code Name

Needle, Biopsy, Cardiovascular

Public Device Record Key

3ead1e89-e5cf-4773-85e3-2b7dbe16df28

Public Version Date

June 14, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2020

Package DI Number

20811870034910

Quantity per Package

10

Contains DI Package

00811870034916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA