Catalog Number

08120-18

Brand Name

Temena

Version/Model Number

08120-18

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAZ

Product Code Name

Anesthesia Conduction Kit

Public Device Record Key

dd3afe4b-25c8-4ed2-a09a-490202bf3543

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

November 28, 2017

Package DI Number

03700339700561

Quantity per Package

10

Contains DI Package

03700339710560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box