Duns Number:047644935
Device Description: Disposable Tip, Hook Scissor, Sterile Pkg Single
Catalog Number
91740
Brand Name
The Cutting Edge System
Version/Model Number
91740
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103840,K103840
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7f62de19-b1ea-4d18-a700-950880c7349b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
00842102104657
Quantity per Package
10
Contains DI Package
00842102104640
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 882 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |