Duns Number:071595540
Device Description: EPILATION/TELANGIECTASIAS NEEDLE STEALTH ER COATING 30 DEGREE ANGLE, 3/8 Inch NEEDLE ELECT EPILATION/TELANGIECTASIAS NEEDLE STEALTH ER COATING 30 DEGREE ANGLE, 3/8 Inch NEEDLE ELECTRODE
Catalog Number
714-S
Brand Name
NA
Version/Model Number
714-S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2020
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
K800617,K800617,K800617,K800617
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
bbe77330-a1f5-408f-affc-ac7320741666
Public Version Date
September 01, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405014383
Quantity per Package
6
Contains DI Package
30653405014380
Package Discontinue Date
September 01, 2020
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |