Duns Number:927071162
Device Description: SPDE-SL -EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Non-St SPDE-SL -EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Non-Stick Blade, 3 Meter (10') hose
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
SPDE-SL
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
Yes
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
K092732,K143103,K092732,K143103,K092732,K143103
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
df6fcce3-9a11-4441-81d4-f03cba048938
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 2019
Package DI Number
20817325023621
Quantity per Package
4
Contains DI Package
10817325023624
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |