Duns Number:825673239
Device Description: AMSure® TUR/Bladder Irrigation Set Y-Type90" (2886 mm) Overall Length/0.27" (6.8 mm) I.D. AMSure® TUR/Bladder Irrigation Set Y-Type90" (2886 mm) Overall Length/0.27" (6.8 mm) I.D. Non-Pyrogenic
Catalog Number
ABL402
Brand Name
AMSure® TUR/Bladder Irrigation Set Y-Type
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
LJH
Product Code Name
System, Irrigation, Urological
Public Device Record Key
ab6fdae7-763c-41f3-acfe-f8910b9558fa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411005477
Quantity per Package
20
Contains DI Package
10704411005476
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 |