Duns Number:825673239
Device Description: AMSure® Irrigation Tray with Piston SyringeCONTENTS:1 each 1000 cc Outer Tray1 each 500 cc AMSure® Irrigation Tray with Piston SyringeCONTENTS:1 each 1000 cc Outer Tray1 each 500 cc Graduated Container1 each 60 cc Piston Irrigation Syringe1 each Tip Protector1 each Alcohol Prep Pad1 each Large Moisture-Proof Underpad
Catalog Number
AS136
Brand Name
AMSure® Irrigation Tray with Piston 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
2927a28b-da6d-4ce9-b540-40eb48713a1c
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 30, 2018
Package DI Number
40704411008119
Quantity per Package
20
Contains DI Package
10704411008118
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 |