Duns Number:080113296
Device Description: Care Touch Hypodermic Needle, 18g x 1
Catalog Number
-
Brand Name
Care Touch
Version/Model Number
HN181
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
be9d6a06-79c3-4e7c-a37f-e224764b7b87
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
December 30, 2016
Package DI Number
00370393000339
Quantity per Package
10
Contains DI Package
00370393130012
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 |