Duns Number:081067703
Device Description: The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the ph The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
Catalog Number
PCK-05
Brand Name
Putty Convenience Kit, 5cc
Version/Model Number
PCK-05
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"
-
For Single-Use
Yes
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
K022622
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
6ce8d17a-b1cb-417f-8fe9-4e3532b8ffb9
Public Version Date
December 23, 2019
Public Version Number
6
DI Record Publish Date
October 07, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |