Catalog Number

3605441

Brand Name

Integra®

Version/Model Number

3605441

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"

Yes

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

K960100,K960100

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

3c60ecb1-c27c-455c-a519-eff30f5409ac

Public Version Date

December 12, 2019

Public Version Number

3

DI Record Publish Date

May 13, 2019

Package DI Number

30381780527408

Quantity per Package

10

Contains DI Package

10381780527404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case