Duns Number:263373588
Device Description: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images)
Catalog Number
/
Brand Name
spineEOS rod Template
Version/Model Number
KIT0704
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 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"
-
For Single-Use
Yes
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
HWT
Product Code Name
Template
Public Device Record Key
63629a11-9dd1-4564-82ab-6fe4192bce1d
Public Version Date
February 02, 2021
Public Version Number
4
DI Record Publish Date
February 23, 2017
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |