NATRELLE Saline-Filled Breast Implants 68HP-320

GUDID 10888628000391

NATRELLE Sty 68HP-320 Saline Round High

Allergan, Inc.

Saline-filled breast implant, unstructured

• Primary Device ID: 10888628000391
• NIH Device Record Key: a315fe9a-0539-495a-ad00-6e068534f90a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATRELLE Saline-Filled Breast Implants
• Version Model Number: 68HP-320
• Catalog Number: 68HP-320
• Company DUNS: 144796497
• Company Name: Allergan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628000391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990074

FDA Product Code

• FWM: Prosthesis, Breast, Inflatable, Internal, Saline

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-24
• Device Publish Date: 2014-09-17

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

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