Duns Number:036985604
Device Description: The Carbon Fiber T-Shaped Sacral Rest with 2-inch pad attaches to orthopedic table to supp The Carbon Fiber T-Shaped Sacral Rest with 2-inch pad attaches to orthopedic table to support the patient's sacral area.
Catalog Number
BF00073
Brand Name
NA
Version/Model Number
Sacral Rest
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
0132efb1-cbc5-466b-8053-5c1c8f36add7
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 02, 2021
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |