Duns Number:246848147
Device Description: #11 Sterile Blade
Catalog Number
73-0411
Brand Name
Polymer Coated Blades
Version/Model Number
73-0411
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
eb25b418-efa7-4192-9947-c0a15e3e1b5b
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
October 02, 2020
Package DI Number
10620974002250
Quantity per Package
6
Contains DI Package
00620974002253
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 |