Duns Number:069590113
Device Description: SOL-M 1ml Syringe w/Fixed Needle 22G*1 1/2 (Low Dead Space)
Catalog Number
-
Brand Name
SOL-M™ Syringe w/Fixed Needle (Low Dead Space)
Version/Model Number
110401010001
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
1ea37884-4181-4763-9503-f8a90c166fb7
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2017
Package DI Number
20818392015311
Quantity per Package
8
Contains DI Package
10818392015314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 161 |