Catalog Number

-

Brand Name

GRAFTSITE

Version/Model Number

D201045

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

K173110,K173110,K173110

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

96c1922c-0c46-4a83-a55d-91173368d5ba

Public Version Date

July 04, 2019

Public Version Number

3

DI Record Publish Date

December 21, 2018

Package DI Number

25060238201142

Quantity per Package

5

Contains DI Package

15060238201145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Carton