Catalog Number

81-5791-CP

Brand Name

Bioplate®

Version/Model Number

81-5791-CP

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

K062819

Product Code

GXN

Product Code Name

Plate, Cranioplasty, Preformed, Non-Alterable

Public Device Record Key

22be1c6e-a5b0-404f-a475-884f29d0c17a

Public Version Date

February 23, 2022

Public Version Number

3

DI Record Publish Date

February 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-