Catalog Number

SCL-1909

Brand Name

SPIDER SCREW

Version/Model Number

SCL-1909

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071851

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

9c98ad7f-b1c0-4068-91c1-fbc430e844b2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-