NATRELLE Saline-Filled Breast Implants 68HP-425

GUDID 10888628000421

NATRELLE Sty 68HP-425 Saline Round High

Allergan, Inc.

Saline-filled breast implant, unstructured Saline-filled breast implant, unstructured Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface Saline-filled breast implant, unstructured, smooth-surface
Primary Device ID10888628000421
NIH Device Record Key0db47fe6-507d-46ab-b8b1-fbc883b5f487
Commercial Distribution StatusIn Commercial Distribution
Brand NameNATRELLE Saline-Filled Breast Implants
Version Model Number68HP-425
Catalog Number68HP-425
Company DUNS144796497
Company NameAllergan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110888628000421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWMProsthesis, Breast, Inflatable, Internal, Saline

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-24
Device Publish Date2014-09-17

On-Brand Devices [NATRELLE Saline-Filled Breast Implants]

10888628001176NATRELLE 468-620 Saline BIOCELL Shp Full
10888628001169NATRELLE 468-560 Saline BIOCELL Shp Full
10888628001152NATRELLE 468-495 Saline BIOCELL Shp Full
10888628001145NATRELLE 468-450 Saline BIOCELL Shp Full
10888628001138NATRELLE 468-380 Saline BIOCELL Shp Full
10888628001121NATRELLE 468-350 Saline BIOCELL Shp Full
10888628001114NATRELLE 468-300 Saline BIOCELL Shp Full
10888628001107NATRELLE 468-270 Saline BIOCELL Shp Full
10888628001091NATRELLE 468-230 Saline BIOCELL Shp Full
10888628001084NATRELLE 468-195 Saline BIOCELL Shp Full
10888628001077NATRELLE 363LF-690 Sal BIOCELL Shp Full
10888628001060NATRELLE 363LF-620 Sal BIOCELL Shp Full
10888628001053NATRELLE 363LF-560 Sal BIOCELL Shp Full
10888628001046NATRELLE 363LF-510 Sal BIOCELL Shp Full
10888628001039NATRELLE 363LF-450 Sal BIOCELL Shp Full
10888628001022NATRELLE 363LF-410 Sal BIOCELL Shp Full
10888628001015NATRELLE 363LF-370 Sal BIOCELL Shp Full
10888628001008NATRELLE 363LF-330 Sal BIOCELL Shp Full
10888628000995NATRELLE 363LF-300 Sal BIOCELL Shp Full
10888628000988NATRELLE 363LF-260 Sal BIOCELL Shp Full
10888628000971NATRELLE 363LF-230 Sal BIOCELL Shp Full
10888628000964NATRELLE 363LF-200 Sal BIOCELL Shp Full
10888628000957NATRELLE 363LF-170 Sal BIOCELL Shp Full
10888628000940NATRELLE 168-800 Saline BIOCELL Rnd Mod
10888628000933NATRELLE 168-750 Saline BIOCELL Rnd Mod
10888628000926NATRELLE 168-700 Saline BIOCELL Rnd Mod
10888628000919NATRELLE 168-650 Saline BIOCELL Rnd Mod
10888628000902NATRELLE 168-600 Saline BIOCELL Rnd Mod
10888628000896NATRELLE 168-550 Saline BIOCELL Rnd Mod
10888628000889NATRELLE 168-510 Saline BIOCELL Rnd Mod
10888628000872NATRELLE 168-480 Saline BIOCELL Rnd Mod
10888628000865NATRELLE 168-450 Saline BIOCELL Rnd Mod
10888628000858NATRELLE 168-420 Saline BIOCELL Rnd Mod
10888628000841NATRELLE 168-390 Saline BIOCELL Rnd Mod
10888628000834NATRELLE 168-360 Saline BIOCELL Rnd Mod
10888628000827NATRELLE 168-330 Saline BIOCELL Rnd Mod
10888628000810NATRELLE 168-300 Saline BIOCELL Rnd Mod
10888628000803NATRELLE 168-270 Saline BIOCELL Rnd Mod
10888628000797NATRELLE 168-240 Saline BIOCELL Rnd Mod
10888628000780NATRELLE 168-210 Saline BIOCELL Rnd Mod
10888628000773NATRELLE 168-180 Saline BIOCELL Rnd Mod
10888628000766NATRELLE 168-150 Saline BIOCELL Rnd Mod
10888628000759NATRELLE 168-120 Saline BIOCELL Rnd Mod
10888628000742STYLE 163, 780CC IMPLANT
10888628000735STYLE 163, 655CC IMPLANT
10888628000728STYLE 163, 530CC IMPLANT
10888628000711STYLE 163, 440CC IMPLANT
10888628000704STYLE 163, 360CC IMPLANT
10888628000698NATRELLE Style 68LP-680 Saline Round Low
10888628000681NATRELLE Style 68LP-640 Saline Round Low

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