Duns Number:825673239
Device Description: AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 cc1 each Small AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 cc1 each Small Tube Adapter
Catalog Number
AS011P
Brand Name
AMSure® Bulb Irrigation Syringe
Version/Model Number
1
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
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
a8005060-2998-4b6f-9711-30537f0dabd8
Public Version Date
September 06, 2021
Public Version Number
4
DI Record Publish Date
June 05, 2018
Package DI Number
40704411008461
Quantity per Package
50
Contains DI Package
10704411008460
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |