Catalog Number

-

Brand Name

ButtonHole with SteriPick NEEDLE SET

Version/Model Number

BH-7004PE

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

FIE

Product Code Name

Needle, Fistula

Public Device Record Key

9bd6eba7-40e5-4930-a57e-4cb34cb480ec

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

10842289102498

Quantity per Package

250

Contains DI Package

00842289102491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box