DEVICE: SIENTRA Silicone Gel Breast Implant (00812790024322)

Device Identifier (DI) Information

SIENTRA Silicone Gel Breast Implant
10721-285MP
In Commercial Distribution
10721-285MP
Sientra, Inc.
00812790024322
GS1

1
010209877 *Terms of Use
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 285 cc
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Device Characteristics

MR Safe
No
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36197 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.
Obsolete false
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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 [?]
P070004 006
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
Device Size Text, specify: Volume: 285 cc
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Device Record Status

5dfdaaab-cee8-427f-899f-d8a258b7fba6
October 25, 2023
4
October 23, 2015
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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
888-708-0808
customer.experience@sientra.com
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