Duns Number:020417380
Device Description: Safco air/water syringe tip A-dec 5pk
Catalog Number
1020162
Brand Name
Safco air/water syringe tips
Version/Model Number
1020162
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECB
Product Code Name
UNIT, SYRINGE, AIR AND/OR WATER
Public Device Record Key
2c3333b5-73b3-43b5-ac4f-d8cff81e714d
Public Version Date
August 11, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 600 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |