Duns Number:832696038
Device Description: Surgical Clipper Blade General use
Catalog Number
4406
Brand Name
N/A
Version/Model Number
4406
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)
Yes
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
19108167-551f-4132-b754-66acab402b0d
Public Version Date
April 02, 2019
Public Version Number
1
DI Record Publish Date
March 25, 2019
Package DI Number
20885403473149
Quantity per Package
50
Contains DI Package
10885403473142
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |