Duns Number:094439676
Device Description: Bifurcated Drain Extension for Closed Wound Drain
Catalog Number
-
Brand Name
Axiom®
Version/Model Number
3600
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
GBS
Product Code Name
Catheter, Ventricular, General & Plastic Surgery
Public Device Record Key
6c38bd2d-c020-4e9f-9c16-703939141c28
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 13, 2020
Package DI Number
M66536001
Quantity per Package
10
Contains DI Package
M66536000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 187 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |