Duns Number:486711679
Device Description: 2.0MM RAPID RESORBABLE CORTEX SCREW 8MM-STERILE
Catalog Number
80600804S
Brand Name
RapidSorb
Version/Model Number
806.008.04S
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
K030069,K062789,K030069,K062789
Product Code
JEY
Product Code Name
PLATE, BONE
Public Device Record Key
6051cbe3-500b-4a9c-af19-8f200db45fa2
Public Version Date
April 25, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2015
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |