DEVICE: MENTOR MemoryShape Breast Implant (00081317005490)

Device Identifier (DI) Information

MENTOR MemoryShape Breast Implant
3541408
In Commercial Distribution
354-1408
MENTOR TEXAS L.P.
00081317005490
GS1

1
167450993 *Terms of Use
Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 440cc |Textured|Contour|Silicone|
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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
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FDA Product Code

[?]
Product Code Product Code Name
FTR Prosthesis, breast, noninflatable, internal, silicone gel-filled
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P060028 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

40cad45e-d72f-42f6-997d-c83b88040e40
February 11, 2021
5
September 17, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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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