Catalog Number

BL-1152

Brand Name

N/A

Version/Model Number

BL-1152

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

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

53ccac55-b459-48f4-8a68-8a30dc593cf6

Public Version Date

August 23, 2021

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

10385640000717

Quantity per Package

6

Contains DI Package

00385640000710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box