DEVICE: MENTOR MemoryGel Resterilizable Gel Sizer (00081317008057)
Device Identifier (DI) Information
MENTOR MemoryGel Resterilizable Gel Sizer
RSZ7425MCS
In Commercial Distribution
RSZ-7425MCS
MENTOR TEXAS L.P.
RSZ7425MCS
In Commercial Distribution
RSZ-7425MCS
MENTOR TEXAS L.P.
Moderate Classic Profile, MC 425cc Gel Sizer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
58856 | Invasive breast implant sizer, fixed, reusable |
A device 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRD | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K062421 | 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
6b78e56a-d211-4548-9338-9518591588d1
December 21, 2020
5
November 03, 2017
December 21, 2020
5
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