DEVICE: MENTOR MemoryGel Resterilizable Gel Sizer (00081317007623)

Device Identifier (DI) Information

MENTOR MemoryGel Resterilizable Gel Sizer
RSZ5501S
In Commercial Distribution
RSZ-5501S
MENTOR TEXAS L.P.
00081317007623
GS1

1
167450993 *Terms of Use
Moderate Plus Profile, M+ 550cc Gel Sizer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
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?
58856 Invasive breast implant sizer, fixed, reusable
A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device is typically composed of a silicone rubber shell with a single-lumen, filled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a reusable device intended to be resterilized between patient applications.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MRD SIZER, MAMMARY, BREAST IMPLANT VOLUME
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062421 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

573f6f63-b84a-4076-abee-75af06ffec63
December 21, 2020
5
November 03, 2017
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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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