Duns Number:009120817
Device Description: Cranial screw - short+long box Qty 4 (2 each)
Catalog Number
-
Brand Name
Cranial Screw - Short/Long
Version/Model Number
P1006801003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
K142560,K142560
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
d4630a18-93f5-433e-9809-c472ece1cfa9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10899475002162
Quantity per Package
10
Contains DI Package
00899475002165
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 |