Duns Number:246848147
Device Description: Safety Cartridge with Southmedic Plus Surgical Blade
Catalog Number
73-8021
Brand Name
SPSS Cartridges
Version/Model Number
73-8021
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
GES
Product Code Name
BLADE, SCALPEL
Public Device Record Key
8c5169c6-7b2b-4df8-b076-977e1d4416f9
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 2020
Package DI Number
10620974002632
Quantity per Package
3
Contains DI Package
00620974002635
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |