Duns Number:536935331
Device Description: The radel implants tray is part of the container with reference 129950ND used in the trans The radel implants tray is part of the container with reference 129950ND used in the transport and the sterilization of the associated instruments.The transport and sterilization containers are not intended to maintain sterility.
Catalog Number
-
Brand Name
CALCANEA™
Version/Model Number
129951ND
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
fd211d82-1232-4bee-be1d-9fbb1c19b465
Public Version Date
July 08, 2021
Public Version Number
6
DI Record Publish Date
May 26, 2017
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |