Duns Number:080300717
Device Description: Shim, 12mm or 14mm x 25 mm, 6 degree, FlareHawk 9
Catalog Number
FHPAS30623X
Brand Name
FlareHawk
Version/Model Number
CMP-00108
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
K182114
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
d388dfae-9588-4735-a7f3-cbc7d5b2244d
Public Version Date
May 13, 2022
Public Version Number
3
DI Record Publish Date
August 07, 2019
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 | 787 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1255 |