Duns Number:825673239
Device Description: AMSure® Urethral Catheterization TrayCONTENTS:1 each Red Rubber Urethral Catheter, 1 each AMSure® Urethral Catheterization TrayCONTENTS:1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup
Catalog Number
AS87118
Brand Name
AMSure® Urethral Catheterization Tray
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
ac5acea5-de31-4d32-a85a-264dfd44bcee
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411003800
Quantity per Package
20
Contains DI Package
10704411003809
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 |