Duns Number:084527241
Catalog Number
6855D-6
Brand Name
PKIT HANA HIP AATHA, ARTHRO, TRAUMA
Version/Model Number
6855D-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
343c7ec6-99b7-460a-a0a8-032fd37fdfb2
Public Version Date
August 31, 2021
Public Version Number
2
DI Record Publish Date
May 03, 2021
Package DI Number
10842430115421
Quantity per Package
6
Contains DI Package
00842430115424
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
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 |