Duns Number:031284586
Device Description: DERMACLOSE XL is a continuous external tissue expander for rapid tissue movement to reduce DERMACLOSE XL is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate larger wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more devices may be used for hours or days. After expansion, remove device and suture or staple the wound closed.
Catalog Number
580100002010
Brand Name
DERMACLOSE
Version/Model Number
GEM204020-K
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"
-
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
MKY
Product Code Name
SYSTEM, SKIN CLOSURE
Public Device Record Key
9d423052-64e8-4388-a727-99f951906800
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |