DEVICE: NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (10888628002616)
Device Identifier (DI) Information
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
FF-410160
Not in Commercial Distribution
FF-410160
Allergan, Inc.
FF-410160
Not in Commercial Distribution
FF-410160
Allergan, Inc.
STYLE 410, FF, 160G
Device Characteristics
MR Safe | |
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. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 160 cc |
Device Record Status
8c874012-e412-4a9b-b31a-b88276aa99c0
December 10, 2021
1
February 20, 2013
December 10, 2021
1
February 20, 2013
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
8006244261
ProductSupport@allergan.com
ProductSupport@allergan.com