Duns Number:080113296
Device Description: Care Touch 3ml Luer Lock Syringe with Needle, 25g x 5/8"
Catalog Number
-
Brand Name
Care Touch
Version/Model Number
SLN2558
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"
Yes
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
K130230,K130230,K130230
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
0f30b4a1-412f-4dee-8de7-78a4f8f0a2dd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 30, 2016
Package DI Number
10370393560014
Quantity per Package
12
Contains DI Package
00370393560017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |