Catalog Number

SP-2643

Brand Name

1.5MM SYSTEM

Version/Model Number

SP-2643

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

K121589,K121624,K953385

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Public Device Record Key

03aa6a56-83a8-4c99-b0b8-d800d29786d1

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-