Duns Number:046189866
Catalog Number
46-1501
Brand Name
TraumaOne SYSTEM
Version/Model Number
46-1501
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
bfa2c383-4ba2-4bec-bc33-d34a8243113c
Public Version Date
July 27, 2020
Public Version Number
2
DI Record Publish Date
September 07, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1783 |
2 | A medical device with a moderate to high risk that requires special controls. | 11874 |
3 | A medical device with high risk that requires premarket approval | 34 |