Duns Number:080664372
Device Description: Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas.
Catalog Number
M01-0-0005
Brand Name
Quickloop Abscess Treatment Device
Version/Model Number
M01-0-0005
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
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
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
97575564-457e-4d18-8c1b-93ed9eab1b9a
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 2021
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 | 1 |