Catalog Number

-

Brand Name

8mm HTR Implant System, Sterile

Version/Model Number

220-08-003

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

K121008

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

986f3a00-a54a-4c61-b5ac-d06c5ac7a7dd

Public Version Date

April 06, 2022

Public Version Number

5

DI Record Publish Date

July 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-