Catalog Number

5700104

Brand Name

Henry Schein

Version/Model Number

5700104

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

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Public Device Record Key

ab18d79c-3f59-4135-8fd4-52b28def1f3d

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

20304040051584

Quantity per Package

12

Contains DI Package

10304040051587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-