Catalog Number

SER2692642

Brand Name

BIO1-KIT

Version/Model Number

BIO1-KIT pre-loaded syringe with Ø3 mm granules

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2020

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

K061022

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

66016e86-be12-49da-a1aa-3efe3922f115

Public Version Date

January 10, 2020

Public Version Number

4

DI Record Publish Date

October 13, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-