Catalog Number

-

Brand Name

TULSA-PRO

Version/Model Number

103705

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

-

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

K191200

Product Code

PLP

Product Code Name

High Intensity Ultrasound System For Prostate Tissue Ablation

Public Device Record Key

c6333602-baf3-475d-bc25-e59288feeeef

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

October 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-