Catalog Number

RSG-14

Brand Name

RSG-14

Version/Model Number

RSG-14

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Public Device Record Key

c4070631-b7d7-4b49-9002-c213a9ea4192

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 19, 2019

Package DI Number

20857878007808

Quantity per Package

15

Contains DI Package

10857878007801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE