Duns Number:123369238
Device Description: The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Catalog Number
-
Brand Name
Craniectomy Template Kit
Version/Model Number
CT-01-K
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P100026,P100026
Product Code
PFN
Product Code Name
Implanted brain stimulator for epilepsy
Public Device Record Key
2c422a2a-6ebb-4f6a-b39c-26daa2bd5dc5
Public Version Date
March 24, 2020
Public Version Number
1
DI Record Publish Date
March 16, 2020
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. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 33 |