Catalog Number

-

Brand Name

IRRIGATION BAG SPIKE ASSEMBLY FOR SYNERGY DRILL SYSTEM

Version/Model Number

325505

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

-

Product Code

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

fe467fa1-8653-41e6-a0e5-d560ffff13ae

Public Version Date

November 22, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2018

Package DI Number

00821925020146

Quantity per Package

6

Contains DI Package

00821925040274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-