Catalog Number

-

Brand Name

Clint Pharmaceuticals

Version/Model Number

ACL11RX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2019

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

-

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

-

FDA Premarket Submission

K965017,K965017

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

ffe7cf05-6cec-486c-abc9-52b7b1e59eca

Public Version Date

October 08, 2019

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

30351688080152

Quantity per Package

30

Contains DI Package

20351688080155

Package Discontinue Date

August 13, 2019

Package Status

Not in Commercial Distribution

Package Type

Case