MENTOR SILTEX Round SPECTRUM 3542430M

GUDID 00081317002079

Post-Operatively Adjustable Saline Breast Implant, 225cc

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface Saline-filled breast implant, unstructured, textured-surface

• Primary Device ID: 00081317002079
• NIH Device Record Key: e30aad06-16b1-441a-bf43-c9df8f6388ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR SILTEX Round SPECTRUM
• Version Model Number: 3542430M
• Catalog Number: 3542430M
• 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: true
• 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: false
• 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	00081317002079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990075

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: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2014-09-17

On-Brand Devices [MENTOR SILTEX Round SPECTRUM]

• 00081317002123: Post-Operatively Adjustable Saline Breast Implant, 475cc
• 00081317002116: Post-Operatively Adjustable Saline Breast Implant, 425cc
• 00081317002109: Post-Operatively Adjustable Saline Breast Implant, 375cc
• 00081317002093: Post-Operatively Adjustable Saline Breast Implant, 325cc
• 00081317002086: Post-Operatively Adjustable Saline Breast Implant, 275cc
• 00081317002079: Post-Operatively Adjustable Saline Breast Implant, 225cc
• 00081317002062: Post-Operatively Adjustable Saline Breast Implant, 175cc
• 00081317002055: Post-Operatively Adjustable Saline Breast Implant, 125cc