Duns Number:315018218
Device Description: CUTFIX Disposable Scalpel, polymer handle, Fig. 20, stainless steel, sterile, disposable, CUTFIX Disposable Scalpel, polymer handle, Fig. 20, stainless steel, sterile, disposable, package of 10 pieces
Catalog Number
5518067
Brand Name
CUTFIX
Version/Model Number
5518067
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
GDX
Product Code Name
SCALPEL, ONE-PIECE
Public Device Record Key
9533c1c4-8149-458f-bbfe-bef6d54277a8
Public Version Date
June 25, 2020
Public Version Number
1
DI Record Publish Date
June 17, 2020
Package DI Number
04038653472642
Quantity per Package
50
Contains DI Package
04038653864928
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |