Duns Number:009120817
Device Description: Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 0 Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit
Catalog Number
-
Brand Name
HeadFrame Kit w/20 Short + 20 Long Head Screws
Version/Model Number
P1006805005
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180586
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
d1db0441-c1c9-4a5d-92a4-ca80a2bb14c8
Public Version Date
January 25, 2021
Public Version Number
1
DI Record Publish Date
January 16, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 253 |