Catalog Number

CRF-TN

Brand Name

TempNeedleCRF

Version/Model Number

CRF-TN

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

K192715,K192715

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

3a190c37-e5bd-418b-9e1f-f3a85ce43b87

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Package DI Number

10811746030377

Quantity per Package

10

Contains DI Package

00811746030370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-