Catalog Number

81-3596

Brand Name

Bioplate@

Version/Model Number

81-3596

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2022

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

K070901

Product Code

GXN

Product Code Name

Plate, Cranioplasty, Preformed, Non-Alterable

Public Device Record Key

6a927b80-408f-4c30-afc3-2abf8fb01d61

Public Version Date

February 23, 2022

Public Version Number

6

DI Record Publish Date

December 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-