Catalog Number

ST 5011

Brand Name

Tryon

Version/Model Number

ST 5011

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

K200992

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

adc557a3-d9e2-432f-a1ac-8a24b7cba656

Public Version Date

July 06, 2022

Public Version Number

1

DI Record Publish Date

June 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-