Catalog Number

SU3985

Brand Name

V. Mueller

Version/Model Number

SU3985

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 23, 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"

-

For Single-Use

-

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

-

Product Code

GEJ

Product Code Name

CARRIER, LIGATURE

Public Device Record Key

8d054e72-b2ae-46da-953f-7672525962b1

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-