Catalog Number

-

Brand Name

Safe-T-Surg

Version/Model Number

2804-01-0001

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

1c9bf2c7-dd44-49a6-8631-f692307ac231

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

20865082000164

Quantity per Package

4

Contains DI Package

10865082000167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box