MENTOR MemoryShape Breast Implant 3541308

GUDID 00081317005476

Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 355cc

MENTOR TEXAS L.P.

Silicone gel-filled breast implant, textured-surface

• Primary Device ID: 00081317005476
• NIH Device Record Key: 27ed216d-533c-47be-a332-cf4060fd1fde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryShape Breast Implant
• Version Model Number: 3541308
• Catalog Number: 3541308
• Company DUNS: 167450993
• Company Name: MENTOR TEXAS L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx
• Phone: +1(800)235-5731
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081317005476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060028

FDA Product Code

• FTR: Prosthesis, breast, noninflatable, internal, silicone gel-filled

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-06
• Device Publish Date: 2014-09-17

On-Brand Devices [MENTOR MemoryShape Breast Implant]

• 00081317024279: TH Tall Height, High Profile 755cc
• 00081317024262: TH Tall Height, High Profile 680cc
• 00081317024255: TH Tall Height, High Profile 610cc
• 00081317024248: TH Tall Height, High Profile 545cc
• 00081317024231: TH Tall Height, High Profile 485cc
• 00081317024224: TH Tall Height, High Profile 430cc
• 00081317024217: TH Tall Height, High Profile 380cc
• 00081317024200: TH Tall Height, High Profile 330cc
• 00081317024194: TH Tall Height, High Profile 290cc
• 00081317024187: TH Tall Height, High Profile 250cc
• 00081317024170: TH Tall Height, High Profile 215cc
• 00081317024163: TH Tall Height, High Profile 180cc
• 00081317005537: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 775cc
• 00081317005520: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 640cc
• 00081317005513: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 530cc
• 00081317005506: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 480cc
• 00081317005490: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 440cc
• 00081317005483: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 395cc
• 00081317005476: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 355cc
• 00081317005469: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 315cc
• 00081317005452: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 280cc
• 00081317005445: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 245cc
• 00081317005438: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 215cc
• 00081317005421: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 180cc
• 00081317005414: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 155cc
• 00081317005407: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 135cc
• 00081317005391: Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 120cc
• 00081317005384: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 650cc
• 00081317005377: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 585cc
• 00081317005360: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 525cc
• 00081317005353: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 475cc
• 00081317005346: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 420cc
• 00081317005339: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 375cc
• 00081317005322: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 330cc
• 00081317005315: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 295cc
• 00081317005308: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 255cc
• 00081317005292: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 225cc
• 00081317005285: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 195cc
• 00081317005278: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 165cc
• 00081317005261: Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 140cc
• 00081317005254: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 685cc
• 00081317005247: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 620cc
• 00081317005230: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 555cc
• 00081317005223: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 495cc
• 00081317005216: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 440cc
• 00081317005209: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 390cc
• 00081317005193: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 345cc
• 00081317005186: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 300cc
• 00081317005179: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 260cc
• 00081317005162: Medium Height, High Profile Silicone Gel-Filled Breast Implant, 225cc