Catalog Number

-

Brand Name

SURGUARD3

Version/Model Number

SG3-03L2516

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

K122249,K122249,K122249

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

7eca4746-ba5d-48f1-88eb-d4f064127f6e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

54806017508437

Quantity per Package

4

Contains DI Package

34806017508433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton