Duns Number:825673239
Device Description: AMSure® Flat Top Piston Irrigation SyringeContents: • 1 Flat Top Piston Irrigation Syringe AMSure® Flat Top Piston Irrigation SyringeContents: • 1 Flat Top Piston Irrigation Syringe, 60ml/2oz • 1 Tip Protector • 1 Small Tube AdapterCaution: Proceed with irrigation procedure, using approved technique.
Catalog Number
AS115
Brand Name
AMSure® Flat Top Piston 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
db662985-1549-4b4a-8f4f-08e29a996d7c
Public Version Date
November 15, 2018
Public Version Number
1
DI Record Publish Date
October 15, 2018
Package DI Number
40704411010150
Quantity per Package
50
Contains DI Package
10704411010159
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 |