Catalog Number

SCR8-04-05[US]

Brand Name

Bioplate®

Version/Model Number

SCR8-04-05[US]

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953273,K953273

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

60fef5c0-722d-436c-ab1f-03f17c63b274

Public Version Date

February 23, 2022

Public Version Number

4

DI Record Publish Date

June 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-