Catalog Number

-

Brand Name

ULTRAGLIDE

Version/Model Number

283

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

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

fbcbfa34-ccfd-431e-8c17-3ce353fed239

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

May 09, 2018

Package DI Number

30857182006013

Quantity per Package

20

Contains DI Package

40857182006010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS