Duns Number:084527241
Device Description: Patient Care Kit includes a Supine-Lateral Headrest Pillow, a Padded Perineal Post Cover, Patient Care Kit includes a Supine-Lateral Headrest Pillow, a Padded Perineal Post Cover, a pair of Armboard Pads and Soft Straps, a pair of Ball Joint Fluid Protectors, and a pair of boot liners.
Catalog Number
6851
Brand Name
Pkit, Hana & ProFx, W/Boot Liner
Version/Model Number
6851-1
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
Yes
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
f64e8c89-5b6f-4c52-8bce-0e1d62efd9fa
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
August 22, 2017
Package DI Number
10842430101875
Quantity per Package
6
Contains DI Package
00842430101878
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bulk pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |