Catalog Number

BL-2009

Brand Name

N/A

Version/Model Number

BL-2009

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 10, 2020

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

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

1b1e5427-87ac-4933-9e5a-77ca2e5a9d37

Public Version Date

August 23, 2021

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

10385640000823

Quantity per Package

6

Contains DI Package

00385640000826

Package Discontinue Date

November 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Box