Duns Number:028137605
Device Description: Cervical IBD 7x18x14 Planar, 6 Deg, 0.16 cc
Catalog Number
-
Brand Name
Tranquil-C™
Version/Model Number
522283
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K170297,K181483
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
37b8d3eb-53ef-4371-ad75-4aa8d680e82b
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 17, 2021
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 | 45 |
2 | A medical device with a moderate to high risk that requires special controls. | 2529 |