Catalog Number

23.0872.00

Brand Name

A-dec

Version/Model Number

23.0872.00

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K931137,K931137,K931137,K931137

Product Code

ECB

Product Code Name

Unit, Syringe, Air And/Or Water

Public Device Record Key

52e91c8c-a0e1-4a16-87fc-cb141bb520a1

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

20194665001978

Quantity per Package

2

Contains DI Package

10194665001971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-