Duns Number:009120817
Device Description: Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Crania Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2
Catalog Number
-
Brand Name
Head Frame Cranial Screws - Long and Short
Version/Model Number
P1006801006
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,K180586
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
483dc247-ca44-403f-8774-b4349cd3c6aa
Public Version Date
January 25, 2021
Public Version Number
1
DI Record Publish Date
January 16, 2021
Package DI Number
10858086006280
Quantity per Package
10
Contains DI Package
00858086006283
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |