Duns Number:796416191
Device Description: BACK BOARD TRACK, SPICA TABLE
Catalog Number
03-1006-0208
Brand Name
Spica Table
Version/Model Number
03-1006-0208
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
JEB
Product Code Name
TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL
Public Device Record Key
163d6755-60c4-43f3-83cf-3b7d68962606
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 15, 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 | 1662 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7273 |