Duns Number:063519193
Device Description: C-arm Equipment Covers Polyurethane Sterile Fits Brainlab Fluoro Registration Kit Rev. 2 1 C-arm Equipment Covers Polyurethane Sterile Fits Brainlab Fluoro Registration Kit Rev. 2 10 per Case
Catalog Number
-
Brand Name
Brainlab
Version/Model Number
26797
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
8ccae755-6179-4155-87d4-8d45e7f36047
Public Version Date
February 20, 2019
Public Version Number
3
DI Record Publish Date
October 12, 2016
Package DI Number
00618125152070
Quantity per Package
10
Contains DI Package
01618125152079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |