Duns Number:002112626
Device Description: AlloX2 Tissue Expander Low Pole Plus-Mid Height Profile, Smooth Surface, w/ Suture Tabs
Catalog Number
AlloX2-12SE
Brand Name
AlloX2 Tissue Expander
Version/Model Number
AlloX2-12SE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 11, 2016
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
LCJ
Product Code Name
Expander, Skin, Inflatable
Public Device Record Key
d0fb639a-b2e6-4542-b6ed-137b7583c659
Public Version Date
September 23, 2019
Public Version Number
4
DI Record Publish Date
September 15, 2015
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 436 |