Duns Number:962768169
Device Description: Cranial 1.7x5mm Self-Tapping Rescue Screw
Catalog Number
2900I-1120
Brand Name
RAAS Cranial Plating System
Version/Model Number
2900I-1120
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 22, 2015
Issuing Agency
In HIBCC
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
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
-
Product Code
GWO
Product Code Name
Plate, cranioplasty, preformed, alterable
Public Device Record Key
8cb928b1-a379-4ec2-8a42-a4a5d446da90
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 18, 2015
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 | 247 |
2 | A medical device with a moderate to high risk that requires special controls. | 291 |