Duns Number:056038268
Catalog Number
47-5300-010-00
Brand Name
FastFrame™
Version/Model Number
47-5300-010-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K152484
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
28ce1b42-19fb-4150-9219-8dff84212999
Public Version Date
June 24, 2020
Public Version Number
4
DI Record Publish Date
September 13, 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 | 8464 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20880 |
| 3 | A medical device with high risk that requires premarket approval | 133 |