Duns Number:144723868
Device Description: Titanium Cranial Implant, Small
Catalog Number
MC-AST10
Brand Name
AccuShape® Titanium Patient-Specific Cranial Implant
Version/Model Number
MC-AST10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K220357
Product Code
GXN
Product Code Name
Plate, Cranioplasty, Preformed, Non-Alterable
Public Device Record Key
dcd9e47d-a28a-4916-b528-dd3d2799ccd8
Public Version Date
September 22, 2022
Public Version Number
1
DI Record Publish Date
September 14, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 103 |