Duns Number:947451626
Device Description: Instrument Tray Mats 254 mm X 254 mm (10 in. x 10 in.)
Catalog Number
15911
Brand Name
Sterrad
Version/Model Number
15911
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
90936cd6-b415-4c0a-abf7-019687bf40be
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
July 31, 2019
Package DI Number
20705037064479
Quantity per Package
2
Contains DI Package
10705037064472
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 |