Natrelle Inspira Cohesive Breast Implants TCM-295

GUDID 10888628030862

Natrelle Inspira TCM 295cc BI (US)

Allergan, Inc.

Silicone gel-filled breast implant Silicone gel-filled breast implant Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface
Primary Device ID10888628030862
NIH Device Record Key70cf7465-9fa2-4f8f-a98f-7f78401bd43c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNatrelle Inspira Cohesive Breast Implants
Version Model NumberTCM-295
Catalog NumberTCM-295
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS110888628030862 [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 Date2016-10-04

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10888628031319Natrelle Inspira TCX 445cc BI (US)
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10888628031289Natrelle Inspira TCX 375cc BI (US)
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10888628031258Natrelle Inspira TCX 285cc BI (US)
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10888628031203Natrelle Inspira TCF 745cc BI (US)
10888628031197Natrelle Inspira TCF 695cc BI (US)
10888628031180Natrelle Inspira TCF 650cc BI (US)
10888628031173Natrelle Inspira TCF 605cc BI (US)
10888628031166Natrelle Inspira TCF 560cc BI (US)
10888628031159Natrelle Inspira TCF 520cc BI (US)
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10888628031128Natrelle Inspira TCF 415cc BI (US)
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10888628031081Natrelle Inspira TCF 335cc BI (US)
10888628031074Natrelle Inspira TCF 325cc BI (US)
10888628031067Natrelle Inspira TCF 295cc BI (US)
10888628031050Natrelle Inspira TCF 265cc BI (US)
10888628031043Natrelle Inspira TCF 240cc BI (US)
10888628031036Natrelle Inspira TCF 220cc BI (US)
10888628031029Natrelle Inspira TCF 200cc BI (US)
10888628031012Natrelle Inspira TCF 180cc BI (US)
10888628031005Natrelle Inspira TCM 755cc BI (US)
10888628030992Natrelle Inspira TCM 685cc BI (US)
10888628030985Natrelle Inspira TCM 640cc BI (US)
10888628030978Natrelle Inspira TCM 600cc BI (US)
10888628030961Natrelle Inspira TCM 560cc BI (US)
10888628030954Natrelle Inspira TCM 520cc BI (US)
10888628030947Natrelle Inspira TCM 485cc BI (US)
10888628030930Natrelle Inspira TCM 445cc BI (US)

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