Catalog Number

-

Brand Name

ButtonHole NEEDLE SET

Version/Model Number

BH-7615

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

59b9c21d-d1b4-4d73-ba73-a3eed22892b9

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

10842289102573

Quantity per Package

250

Contains DI Package

00842289102576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box