Duns Number:063519193
Device Description: Purple C-Bow Drape for 9900, 9800 Elite and CFM Elite, 20 per Case
Catalog Number
-
Brand Name
GE Healthcare
Version/Model Number
33304
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
59ad9551-b2c3-4701-9003-1907d1c069ee
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 18, 2017
Package DI Number
00618125187157
Quantity per Package
20
Contains DI Package
01618125187156
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 |