Duns Number:008124539
Device Description: Disposable Twin Blade Razors
Catalog Number
-
Brand Name
Twin Blade Razors
Version/Model Number
4250
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LWK
Product Code Name
Razor, Surgical
Public Device Record Key
5e9fb56e-d6b5-406d-8993-4ad9b85a7816
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
November 01, 2020
Package DI Number
00616784425023
Quantity per Package
5
Contains DI Package
00616784425016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |