Duns Number:650191174
Device Description: TECHNO CUT STAINLESS STEEL STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #2 TECHNO CUT STAINLESS STEEL STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #25 INDIVIDUALLY PACKED MYCO REORDER # 6008T-25
Catalog Number
03510
Brand Name
TECHNO CUT
Version/Model Number
#25
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
a518c86f-ddd4-4269-99d0-254f49dcea14
Public Version Date
July 09, 2020
Public Version Number
1
DI Record Publish Date
July 01, 2020
Package DI Number
58904233135102
Quantity per Package
1000
Contains DI Package
18904233135104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |