DEVICE: Softspan™ Tissue Expander (M746SREFK270S0)
Device Identifier (DI) Information
Softspan™ Tissue Expander
SRE-FK-270S
Not in Commercial Distribution
SRE-FK-270S
SPECIALTY SURGICAL PRODUCTS INC
SRE-FK-270S
Not in Commercial Distribution
SRE-FK-270S
SPECIALTY SURGICAL PRODUCTS INC
Softspan™ Tissue Expander, Flat Kidney, Remote Injection Port, Smooth Surface, Reinforced Base
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45187 | Skin-port tissue expander |
An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCJ | Expander, Skin, Inflatable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Width: 14.0 Centimeter |
Device Record Status
dccd80c6-0a2b-42e0-b81d-8a6f97eab6ec
September 23, 2019
4
September 15, 2015
September 23, 2019
4
September 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
888-878-0811
customerservice@ssp-inc.com
customerservice@ssp-inc.com