Catalog Number

-

Brand Name

SDS2.2

Version/Model Number

SDS2.2_5414-ov

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190406

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

a955175a-c9f6-4e6b-a7c5-1beaa119af29

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-