Catalog Number

AS8334A

Brand Name

SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III

Version/Model Number

AS8334A

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,K120510

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

0253e8b4-f238-4763-914c-f0324e8230e0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

37290109950809

Quantity per Package

10

Contains DI Package

07290109950808

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-