Duns Number:961027315
Device Description: Rectal Pre-Lubricated Probe Covers, Disposable
Catalog Number
16811-PRBR
Brand Name
CARDINAL HEALTH
Version/Model Number
16811-PRBR
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
3594e41d-a3ea-45d5-b870-96862c7796e5
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
50885380023840
Quantity per Package
20
Contains DI Package
20885380023849
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |