Catalog Number

RO21 /5

Brand Name

Skintact

Version/Model Number

RO21 /5

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"

-

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

d912b0bb-049e-4b67-8e5f-811f56d4e91c

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

29005531591527

Quantity per Package

10

Contains DI Package

19005531591520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box