DEVICE: MENTOR SILTEX Round Moderate Profile (00081317001782)

Device Identifier (DI) Information

MENTOR SILTEX Round Moderate Profile
3542645
In Commercial Distribution
3542645
MENTOR TEXAS L.P.
00081317001782
GS1

1
167450993 *Terms of Use
Saline Breast Implant with Diaphragm Valve, 300cc
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
FWM Prosthesis, breast, inflatable, internal, saline
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P990075 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

08bf9a14-9836-4f05-9997-2bbf0a087682
July 24, 2018
4
September 17, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)235-5731
xx@xx.xx
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