Duns Number:080194935
Device Description: Comfortox Sterile syringes /with needle 3ml/cc 22gx1"
Catalog Number
-
Brand Name
Comfortox
Version/Model Number
3ml/cc 22gx1"
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)
Yes
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
0087a7ed-d0c1-4fa3-bd6e-546a1c6b6b17
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
10817169023521
Quantity per Package
100
Contains DI Package
00817169023524
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| U | Unclassified | 1 |