Duns Number:606417780
Device Description: PrimaLOK FF 40mm Implant Assembly, 2 Pack, Sterile
Catalog Number
800-1140-SP-02
Brand Name
OsteoMed
Version/Model Number
800-1140-SP-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 29, 2017
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
-
Product Code
MRW
Product Code Name
SYSTEM, FACET SCREW SPINAL DEVICE
Public Device Record Key
86f41552-e34b-4095-9412-46362b3eaf9f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 22, 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 | 95 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7762 |
| U | Unclassified | 105 |