Duns Number:303655286
Device Description: For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect For easy closure the Comfort Drain Grasper can be used as a helpful instrument to connect the couplingpiece with the cut / trimmed drain during the implantation of a Comfort Drain.
Catalog Number
CDS2010
Brand Name
Comfort Drain Grasper
Version/Model Number
CDS2010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
GBN
Product Code Name
Catheter, Pediatric, General & Plastic Surgery
Public Device Record Key
12d89bf9-e535-422c-8f4a-f967e475da20
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 29, 2018
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |