Duns Number:531958689
Device Description: The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and Gener The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.
Catalog Number
ND_PRD00088-01
Brand Name
EndyMed Pure 85W system 220V
Version/Model Number
Pure 85W system 220V
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
K120513
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
e01aa8f7-9574-4a7d-8968-49f8f87086ad
Public Version Date
March 21, 2019
Public Version Number
2
DI Record Publish Date
March 03, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |