Duns Number:606417780
Device Description: PrimaLIF 28mm Access Ring Inserter
Catalog Number
810-3028
Brand Name
OsteoMed
Version/Model Number
810-3028
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
-
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
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
adbece8a-f7c5-4dfb-9f93-dee885d8728d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 17, 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 |
---|---|---|
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 |