Duns Number:317326411
Device Description: HSW UNIVERSAL Selffilling ear syringe complete set 10 ml
Catalog Number
2710036800
Brand Name
HSW UNIVERSAL Selffilling ear syringe complete set
Version/Model Number
2710036800
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
-
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
KCP
Product Code Name
Syringe, Ent
Public Device Record Key
abbf6522-dd64-4e95-84ea-f51c5f55d485
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
November 21, 2019
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 | 40 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |