Duns Number:142007082
Device Description: SurgyCut Spatula with Suction & Electrode, 5mm/35cm
Catalog Number
790-127-535
Brand Name
SurgyCut
Version/Model Number
790-127-535
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7d00bc63-7abb-4709-8292-6c08e58777dc
Public Version Date
March 28, 2019
Public Version Number
1
DI Record Publish Date
March 20, 2019
Package DI Number
00810014631813
Quantity per Package
100
Contains DI Package
00810014631790
Package Discontinue Date
-
Package Status
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |