Duns Number:606417780
Device Description: Profile 0 X- Large Bur Hole Plate Sterile Qty 2
Catalog Number
218-0212-SP-02
Brand Name
OsteoMed
Version/Model Number
218-0212-SP-02
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
-
Product Code
GWO
Product Code Name
Plate, cranioplasty, preformed, alterable
Public Device Record Key
c5b9476a-8bea-4820-b261-bbc7b913b0ea
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 02, 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 |