Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

YMCIR-800

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

2ac0511d-ebfa-41cd-ba0f-e0c1a25ad359

Public Version Date

June 21, 2019

Public Version Number

1

DI Record Publish Date

June 13, 2019

Package DI Number

20811870033326

Quantity per Package

20

Contains DI Package

00811870033322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA