Catalog Number

-

Brand Name

Medisystems Button Hole Single Needle Set

Version/Model Number

BH-3005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 06, 2020

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

581f75d0-1e6e-4afc-ab63-2424ad1d89bb

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10842289101156

Quantity per Package

30

Contains DI Package

00842289101159

Package Discontinue Date

July 06, 2020

Package Status

Not in Commercial Distribution

Package Type

-