Duns Number:109903521
Device Description: MTO STRAP TABLE STABILIZATION
Catalog Number
7210568
Brand Name
NA
Version/Model Number
7210568
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FWZ
Product Code Name
Accessories, operating-room, table (kit)
Public Device Record Key
7dffa9e4-8eb4-4745-8f12-48db268cceae
Public Version Date
March 05, 2020
Public Version Number
3
DI Record Publish Date
September 28, 2015
Package DI Number
23596010513810
Quantity per Package
2
Contains DI Package
03596010513816
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |