Duns Number:961027315
Device Description: Disposable Magnetic Instrument Pad; Medium; 10 in. x 16 in.
Catalog Number
200-16B-V
Brand Name
CARDINAL HEALTH
Version/Model Number
200-16B-V
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
99d1435a-5bc3-4a72-b5f8-9ad31b566dbe
Public Version Date
April 30, 2021
Public Version Number
4
DI Record Publish Date
January 01, 2019
Package DI Number
50885380118898
Quantity per Package
48
Contains DI Package
10885380118890
Package Discontinue Date
April 30, 2021
Package Status
Not 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 |