Catalog Number

-

Brand Name

SuperLock

Version/Model Number

SDGN447

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

-

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

d8968d5d-0676-4dc3-8427-a4af5a185c05

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 05, 2021

Package DI Number

20884521762685

Quantity per Package

5

Contains DI Package

10884521762688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE