Duns Number:688441448
Device Description: 1mL 25G x 5/8"
Catalog Number
-
Brand Name
SAFETY SYRINGES, 1cc 25G x 5/8"
Version/Model Number
1258
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)
Yes
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
-
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
18d6d977-1f7c-4ee4-b96d-b55d776898cd
Public Version Date
March 29, 2021
Public Version Number
2
DI Record Publish Date
March 01, 2021
Package DI Number
18800117112585
Quantity per Package
100
Contains DI Package
08800117112588
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |