Duns Number:947451626
Device Description: Instrument Tray Mats 432 mm X 191 mm (17 in. x 7.5 in.)
Catalog Number
99210
Brand Name
Sterrad
Version/Model Number
99210
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
-
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
200cb7b3-c211-4106-a3d1-575a4c81bacf
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
May 31, 2018
Package DI Number
20705037043054
Quantity per Package
2
Contains DI Package
10705037043057
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 159 |