Duns Number:001292192
Device Description: SYRINGE 0.3ML 31G 6MM S/C U-100 ReliOn
Catalog Number
328521
Brand Name
Relion Insulin Syringe, 3/10ml x 6mm
Version/Model Number
328521
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
-
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
5762f265-7e06-4028-996a-2a0c006b206f
Public Version Date
July 13, 2018
Public Version Number
1
DI Record Publish Date
June 12, 2018
Package DI Number
50382903285216
Quantity per Package
500
Contains DI Package
00681131138383
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |