Catalog Number

0705-315-000

Brand Name

iVAS

Version/Model Number

0705315000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2021

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

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Public Device Record Key

d47e15a5-3f58-4080-b276-f03c3d07be08

Public Version Date

November 18, 2021

Public Version Number

9

DI Record Publish Date

September 24, 2015

Package DI Number

37613252505960

Quantity per Package

3

Contains DI Package

07613252505969

Package Discontinue Date

July 08, 2021

Package Status

Not in Commercial Distribution

Package Type

pack