Catalog Number

MC-PLT005

Brand Name

AccuPlate

Version/Model Number

MC-PLT005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K193280

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

094bb855-05a5-4dbc-beb2-c0a7d0a6a5fd

Public Version Date

September 22, 2021

Public Version Number

1

DI Record Publish Date

September 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-