DEVICE: DERMACLOSE (00844735006124)
Device Identifier (DI) Information
DERMACLOSE
GEM204010-K
In Commercial Distribution
580100001010
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM204010-K
In Commercial Distribution
580100001010
SYNOVIS MICRO COMPANIES ALLIANCE, INC
DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more DERMACLOSE may be used for hours - days providing tissue expansion. After expansion, remove device and suture or staple the wound closed
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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33873 | Skin-closing tension device |
A sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MKY | SYSTEM, SKIN CLOSURE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 66 Centimeter |
Device Record Status
11c268be-77d1-49bc-a01c-8b84ecf038d5
April 22, 2019
1
April 12, 2019
April 22, 2019
1
April 12, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
MEDINFO_MEDPRODUCTS@BAXTER.COM
MEDINFO_MEDPRODUCTS@BAXTER.COM