DEVICE: MENTOR MemoryShape Breast Implant (00081317005490)
Device Identifier (DI) Information
MENTOR MemoryShape Breast Implant
3541408
In Commercial Distribution
354-1408
MENTOR TEXAS L.P.
3541408
In Commercial Distribution
354-1408
MENTOR TEXAS L.P.
Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 440cc |Textured|Contour|Silicone|
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64082 | Silicone gel-filled breast implant, textured-surface |
An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTR | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P060028 | 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
40cad45e-d72f-42f6-997d-c83b88040e40
February 11, 2021
5
September 17, 2014
February 11, 2021
5
September 17, 2014
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