Catalog Number

-

Brand Name

SURGUARD2

Version/Model Number

10069495

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

K051865,K051865,K051865

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

9de8bd3d-4f55-473f-ba18-ab4d0cda6831

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

54806017512625

Quantity per Package

12

Contains DI Package

34806017512621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton