Duns Number:069590113
Device Description: SOL-M 1ml Insulin Syringe (PE Bag) 27G x 1/2”
Catalog Number
-
Brand Name
SOL-M Insulin Syringe
Version/Model Number
1612712B
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
7f1ad2df-91d0-4773-ac58-52d84d102a27
Public Version Date
July 10, 2019
Public Version Number
1
DI Record Publish Date
July 02, 2019
Package DI Number
20810018090009
Quantity per Package
10
Contains DI Package
10810018090002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 161 |