Catalog Number

BPNK1-10X

Brand Name

Bent Passing Needle Kit

Version/Model Number

BPNK1-10X

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

HWQ

Product Code Name

PASSER

Public Device Record Key

6b4feb42-5739-4bb5-8691-49135766863c

Public Version Date

August 17, 2021

Public Version Number

1

DI Record Publish Date

August 09, 2021

Package DI Number

90841823100743

Quantity per Package

2

Contains DI Package

00841823100740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-