Catalog Number

03.950.001S

Brand Name

Graft Delivery, DePuy Synthes

Version/Model Number

03-950-001S

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

K173385,K173385,K173385

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

174bf360-cfc9-4071-8833-608c2a34262c

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

June 15, 2018

Package DI Number

20815634020621

Quantity per Package

1

Contains DI Package

10815634020624

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ship Box