DEVICE: MENTOR Smooth Round SPECTRUM (00081317002024)
Device Identifier (DI) Information
MENTOR Smooth Round SPECTRUM
3501480
In Commercial Distribution
3501480
MENTOR TEXAS L.P.
3501480
In Commercial Distribution
3501480
MENTOR TEXAS L.P.
Post Operatively Adjustable Saline Breast Implant, 475cc
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 |
---|---|
Saline-filled breast implant, unstructured | A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWM | Prosthesis, breast, inflatable, internal, saline |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P990075 | 019 |
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
d822cf87-d299-487c-9517-bdf8e1f77ebf
July 24, 2018
4
September 17, 2014
July 24, 2018
4
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