Duns Number:315018218
Device Description: CUTFIX Scalpel Blades, Fig. 36, stainless steel, sterile, disposable, dispenser packaging, CUTFIX Scalpel Blades, Fig. 36, stainless steel, sterile, disposable, dispenser packaging, package of 100 pieces
Catalog Number
16615522
Brand Name
CUTFIX
Version/Model Number
16615522
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
e03df46e-e798-4fc6-afbd-7b5740b49551
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
April 23, 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 | 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 |