DEVICE: MENTOR Tissue Expander (00081317002437)
Device Identifier (DI) Information
MENTOR Tissue Expander
3504307M
In Commercial Distribution
3504307M
MENTOR TEXAS L.P.
3504307M
In Commercial Distribution
3504307M
MENTOR TEXAS L.P.
Smooth Round, 550cc
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Tissue expander | An sterile inflatable device intended to be temporarily implanted to enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of a long-term 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 managed by a healthcare professional. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCJ | EXPANDER, SKIN, INFLATABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K842883 | 000 |
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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No Device Sizes |
Device Record Status
477219a1-4e5e-404d-8795-9f7eee3819a9
July 06, 2018
3
September 14, 2015
July 06, 2018
3
September 14, 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 |
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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)235-5731
xx@xx.xx
xx@xx.xx