Catalog Number

BL-2005

Brand Name

N/A

Version/Model Number

BL-2005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2021

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

853234f4-6c5c-4f57-94ac-b2ee734a8ec5

Public Version Date

August 23, 2021

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

10385640000779

Quantity per Package

6

Contains DI Package

00385640000772

Package Discontinue Date

June 18, 2021

Package Status

Not in Commercial Distribution

Package Type

Box