Duns Number:989772017
Device Description: 10ml Suresafe Automatic Retractable Syringe - 21G x 1 1/2" - Sterile
Catalog Number
FD-SSIC10-21
Brand Name
10ml Suresafe Syringe
Version/Model Number
10ml Syringe - 21G x 1 1/2"
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143497,K143497,K143497
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
bedcde8d-7306-4dc9-9a4d-203990b7d835
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 2016
Package DI Number
05391530750684
Quantity per Package
8
Contains DI Package
05391530750677
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |