Duns Number:078572603
Device Description: Ear/Ulcer Bulb Syringe, 3 oz. (90ml), Sterile
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS0910-3
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
37b52d55-8360-41c6-bbe6-4159e8c5b070
Public Version Date
May 20, 2021
Public Version Number
2
DI Record Publish Date
December 31, 2019
Package DI Number
10849027002997
Quantity per Package
50
Contains DI Package
00849027002990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |