Duns Number:072943876
Device Description: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
Catalog Number
-
Brand Name
TopCare Insulin Syringe
Version/Model Number
052912
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
K062702,K062702,K062702
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
f810b897-e78c-4a00-ab58-7e542f8e0d55
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10036800250779
Quantity per Package
30
Contains DI Package
00036800250772
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |