Duns Number:007941230
Device Description: Tray Foley Insertion With 1000 Milliliter Outer Basin Tray 10 Cubic Centimeter Pre-Filled Tray Foley Insertion With 1000 Milliliter Outer Basin Tray 10 Cubic Centimeter Pre-Filled Syringe Of Sterile Water 1 Pair Vinyl Gloves 1 Waterproof Drape 1 Fenestrated Drape 1 3 Gram Pack Lubricating Jelly 3 Pvp Swab Sticks Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
INTRAY80
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
FCM
Product Code Name
Tray, catheterization, sterile urethral, with or without catheter (kit)
Public Device Record Key
372a3fb3-ae47-460f-b80d-f3dd1ad72a3f
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632100428
Quantity per Package
20
Contains DI Package
10885632100420
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |