Duns Number:008171162
Device Description: Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a ster Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
Catalog Number
-
Brand Name
ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16"
Version/Model Number
250311
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"
-
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
K132681,K132681,K132681
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
21cc0795-0db3-4851-b255-1e7ddfe52c5d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2017
Package DI Number
20015482503110
Quantity per Package
8
Contains DI Package
10015482503113
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |