Duns Number:868042664
Device Description: Device designed to be used in postless hip arthroscopy procedures to protect the patient f Device designed to be used in postless hip arthroscopy procedures to protect the patient from movement and injury
Catalog Number
-
Brand Name
The Pink Hip Kit - Hana
Version/Model Number
HIP40615H
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)
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
e947d03e-1e98-4df8-91ae-4432840592b8
Public Version Date
March 25, 2022
Public Version Number
1
DI Record Publish Date
March 17, 2022
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |