DEVICE: MENTOR MemoryShape LM Plus Resterilizable Gel Sizer (00081317008859)
Device Identifier (DI) Information
MENTOR MemoryShape LM Plus Resterilizable Gel Sizer
RSZ1357S
In Commercial Distribution
RSZ1357S
MENTOR TEXAS L.P.
RSZ1357S
In Commercial Distribution
RSZ1357S
MENTOR TEXAS L.P.
Low Height, Moderate Plus Profile Sterile, 415cc
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Invasive breast implant sizer, reusable | A sterile surgical instrument intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device is typically composed of a silicone rubber shell with a single lumen, filled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a reusable device intended to be resterilized between patient applications. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRD | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
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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No Device Sizes |
Device Record Status
40ea7fe0-e9d8-49f5-adb5-2a643736da92
March 29, 2018
2
November 03, 2017
March 29, 2018
2
November 03, 2017
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)235-5731
xx@xx.xx
xx@xx.xx