Catalog Number

IQSP-PP-102

Brand Name

Inqu

Version/Model Number

Paste Mix Plus

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K103799

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

202e39d4-adb1-466a-8b50-b651702ef300

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-