Catalog Number

ESS14-02

Brand Name

Integra®

Version/Model Number

ESS14-02

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K945484,K945484,K945484

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

e7e04124-501a-4fc2-b493-4f119ffcbf8e

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

June 20, 2018

Package DI Number

30381780431705

Quantity per Package

10

Contains DI Package

10381780431701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case