Duns Number:650191174
Device Description: TECHNO CUT HIGH CARBON STAINLESS STEEL STERILE SURGICAL BLADE # 21 WITH SILICON COATING I TECHNO CUT HIGH CARBON STAINLESS STEEL STERILE SURGICAL BLADE # 21 WITH SILICON COATING INDIVIDUALLY PACKED
Catalog Number
03745
Brand Name
TECHNO CUT
Version/Model Number
#21
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
6877644b-4d8c-43a0-91f5-63d2f74a07a2
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2020
Package DI Number
28904233137457
Quantity per Package
1000
Contains DI Package
18904233137450
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 | 1 |