Duns Number:080935429
Device Description: Hydrogel Coated Latex Foley Insertion Tray,Prep Deck
Catalog Number
2101
Brand Name
Dover
Version/Model Number
2101
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
fa7958ba-4bdf-4af5-bc83-2d9ee83e001c
Public Version Date
February 23, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521025551
Quantity per Package
20
Contains DI Package
10884521025554
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |