Catalog Number

AS83333

Brand Name

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

Version/Model Number

AS83333

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

-

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

K120510,K120510

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

e470be81-b676-46cb-a015-c60c122f3a14

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2017

Package DI Number

17290109952694

Quantity per Package

5

Contains DI Package

07290109952697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-