NATRELLE 410 Highly Cohesive Anatomically Shaped S FX-410450

GUDID 10888628002999

STYLE 410, FX, 450 CC

Allergan, Inc.

Silicone gel-filled breast implant
Primary Device ID10888628002999
NIH Device Record Keye28ad7d5-85eb-4634-a27e-340e9cd528eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNATRELLE 410 Highly Cohesive Anatomically Shaped S
Version Model NumberFX-410450
Catalog NumberFX-410450
Company DUNS144796497
Company NameAllergan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com
Phone8006244261
EmailProductSupport@allergan.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110888628002999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-11-20

On-Brand Devices [NATRELLE 410 Highly Cohesive Anatomically Shaped S]

10888628003798STYLE 410, MX, 685G
10888628003781STYLE 410, MX, 620G
10888628003774STYLE 410, MX, 550G
10888628003767STYLE 410, MX, 520G
10888628003750STYLE 410, MX, 445G
10888628003743STYLE 410, MX, 410G
10888628003736STYLE 410, MX, 370G
10888628003729STYLE 410, MX, 325G
10888628003712STYLE 410, MX, 290G
10888628003705STYLE 410, MX, 255G
10888628003699STYLE 410, MX, 225G
10888628003682STYLE 410, MX, 195G
10888628003675STYLE 410, MX, 165G
10888628003668NATRELLE 410 STYLE MM 450CC
10888628003651NATRELLE 410 STYLE MM 400CC
10888628003644NATRELLE 410 STYLE MM 360CC
10888628003637NATRELLE 410 STYLE MM 320CC
10888628003620NATRELLE 410 STYLE MM 280CC
10888628003613NATRELLE 410 STYLE MM 245CC
10888628003606NATRELLE 410 STYLE MM 215CC
10888628003590NATRELLE 410 STYLE MM 185CC
10888628003583NATRELLE 410 STYLE MM 160CC
10888628003576STYLE 410, ML, 285G
10888628003569STYLE 410, ML, 220G
10888628003552STYLE 410, ML, 195G
10888628003545STYLE 410, ML, 170G
10888628003538STYLE 410, ML, 125G
10888628003521NATRELLE 410 STYLE MF 640CC
10888628003514NATRELLE 410 STYLE MF 580CC
10888628003507NATRELLE 410 STYLE MF 525CC
10888628003491NATRELLE 410 STYLE MF 470CC
10888628003484NATRELLE 410 STYLE MF 420CC
10888628003477NATRELLE 410 STYLE MF 375CC
10888628003460NATRELLE 410 STYLE MF 335CC
10888628003453NATRELLE 410 STYLE MF 295CC
10888628003446NATRELLE 410 STYLE MF 255CC
10888628003439NATRELLE 410 STYLE MF 225CC
10888628003422NATRELLE 410 STYLE MF 195CC
10888628003415NATRELLE 410 STYLE MF 165CC
10888628003408NATRELLE 410 STYLE MF 140CC
10888628003354STYLE 410, LX, 405G
10888628003347STYLE 410, LX, 365G
10888628003330STYLE 410, LX, 330G
10888628003323STYLE 410, LX, 290G
10888628003316STYLE 410, LX, 255G
10888628003309STYLE 410, LX, 225G
10888628003293STYLE 410, LX, 195G
10888628003286STYLE 410, LX, 175G
10888628003279STYLE 410, LX, 145G
10888628003262STYLE 410, LM, 320G

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.