Duns Number:081253414
Device Description: KIT, CT POSITIONING. Includes 105 - WEDGE, 3.75” x 9” x 8”, (10810050242995), 106 - WEDGE, KIT, CT POSITIONING. Includes 105 - WEDGE, 3.75” x 9” x 8”, (10810050242995), 106 - WEDGE, 6.63” x 6.63” x 12” (00810050242318), 113 - WEDGE, 2.25” x 9.5” x 7.25”, (10810050242926), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 120 - WEDGE, 2.50” x 8” x 7” (00810050242301), 123 - WEDGE, 6.63” x 9” x 12” (00810050242325), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)
Catalog Number
-
Brand Name
NA
Version/Model Number
99
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
2121973d-a3e3-4b79-9b30-f5e11d1e2299
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 13, 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 | 512 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |