Duns Number:532685716
Device Description: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
Catalog Number
AS87512
Brand Name
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
Version/Model Number
AS87512
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
3d80a0ff-21b3-487d-a1bd-be989220754b
Public Version Date
March 31, 2020
Public Version Number
4
DI Record Publish Date
June 01, 2017
Package DI Number
17290109952700
Quantity per Package
5
Contains DI Package
07290109952703
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 194 |