DEVICE: MENTOR MemoryGel Breast Implant (00081317000723)
Device Identifier (DI) Information
MENTOR MemoryGel Breast Implant
3544507
In Commercial Distribution
3544507
MENTOR TEXAS L.P.
3544507
In Commercial Distribution
3544507
MENTOR TEXAS L.P.
SILTEX Round Moderate Profile Gel-Filled Breast Implant, 450cc
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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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 |
---|---|
Silicone gel-filled breast implant | A sterile 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 implant may vary in shape, profile, volume, shell surface, and shell thickness. |
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 [?] |
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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
56dd6b5f-33d0-4268-a519-f99e459c8fff
March 29, 2018
2
September 17, 2014
March 29, 2018
2
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