Catalog Number

-

Brand Name

SURGUARD3

Version/Model Number

SG3-2225

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

K113422,K113422,K113422

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

abc537cc-db61-4033-99d2-51795b462574

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 07, 2016

Package DI Number

54806017508154

Quantity per Package

8

Contains DI Package

34806017508150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton