Catalog Number

SPNK1-3.5X

Brand Name

Slotted Passing Needle Kit with Obturator

Version/Model Number

SPNK1-3.5X

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

d4d43194-d588-4c26-a266-b9b0da003dc2

Public Version Date

August 17, 2021

Public Version Number

1

DI Record Publish Date

August 09, 2021

Package DI Number

90841823107919

Quantity per Package

5

Contains DI Package

00841823107916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-