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
N/A
Brand Name
Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm
Version/Model Number
253315
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)
-
Over the Counter (OTC)
Yes
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
5cf1fc6d-e661-4442-bb27-5581f3de7f22
Public Version Date
June 03, 2020
Public Version Number
1
DI Record Publish Date
May 26, 2020
Package DI Number
20015482253152
Quantity per Package
8
Contains DI Package
00015482253158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| 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 |