Duns Number:650191174
Device Description: CARBON STEEL STERILE SURGICAL BLADE #STITCH CUTTER WITH SILICON COATING INDIVIDUALLY PACKE CARBON STEEL STERILE SURGICAL BLADE #STITCH CUTTER WITH SILICON COATING INDIVIDUALLY PACKED MYCO REORDER # 2002-SC
Catalog Number
02014
Brand Name
Not Applicable
Version/Model Number
#STITCH CUTTER
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
f6af39c2-b39c-4765-b18e-c82b8f01dc58
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2020
Package DI Number
28904233120145
Quantity per Package
1000
Contains DI Package
18904233120148
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 |