Duns Number:001483130
Device Description: Carbon Surgical Blades Sterile #15
Catalog Number
12201500
Brand Name
Carbon Surgical Blades Sterile #15
Version/Model Number
12201500
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
-
Prescription Use (Rx)
-
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
37866d3f-e34c-4517-9625-202696be72c0
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
March 06, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 58 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |