Duns Number:002348191
Device Description: 10 mL Luer-Slip Loss of Resistance Syringe
Catalog Number
LR-05501
Brand Name
ARROW
Version/Model Number
IPN040168
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)
Yes
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
90d82dfa-aceb-437e-8501-277732de7d69
Public Version Date
March 04, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
30801902011528
Quantity per Package
25
Contains DI Package
00801902011527
Package Discontinue Date
March 03, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |