Identity
- Trade Name
- DERMACLOSE FDA UDI
- Generic Name
- Skin-closing tension device FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GEM204020-K FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 580100002010 FDA UDI
- Primary DI / UDI-DI
- 00844735006131 FDA UDI
- FDA Product Code
- MKY FDA UDI
- GMDN Term
- Skin-closing tension device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 95.25 Centimeter FDA UDI
Category: Skin-closing tension device
Dermaclose by Synovis Micro Companies Alliance, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI 9d423052-64e8-4388-a727-99f951906800 36 fields · synced May 30, 2026