Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

BTPS 004M

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

OFA

Product Code Name

Cardiovascular Surgical Instruments Tray

Public Device Record Key

58c52e95-3e62-4543-87be-d6c3ea30c1cb

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2019

Package DI Number

20811870032671

Quantity per Package

1

Contains DI Package

00811870032677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA