MENTOR CPX 2 Breast Tissue Expander 3546215

GUDID 00081317002284

SITLEX Medium Height Tissue Expander Style 6200, 650cc

MENTOR TEXAS L.P.

Skin-port tissue expander

• Primary Device ID: 00081317002284
• NIH Device Record Key: b60c5698-e156-4c2a-ac1a-deae7b0219e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR CPX 2 Breast Tissue Expander
• Version Model Number: 3546215
• Catalog Number: 3546215
• 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	00081317002284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011500

FDA Product Code

• LCJ: EXPANDER, SKIN, INFLATABLE

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: 2019-09-23
• Device Publish Date: 2015-09-07

On-Brand Devices [MENTOR CPX 2 Breast Tissue Expander]

• 00081317002369: SILTEX Tall Height Tissue Expander Style 6300, 850cc
• 00081317002352: SILTEX Tall Height Tissue Expander Style 6300, 750cc
• 00081317002345: SILTEX Tall Height Tissue Expander Style 6300, 650cc
• 00081317002338: SILTEX Tall Height Tissue Expander Style 6300, 550cc
• 00081317002321: SILTEX Tall Height Tissue Expander Style 6300, 450cc
• 00081317002314: SILTEX Tall Height Tissue Expander Style 6300, 350cc
• 00081317002307: SILTEX Tall Height Tissue Expander Style 6300, 250cc
• 00081317002291: SITLEX Medium Height Tissue Expander Style 6200, 800cc
• 00081317002284: SITLEX Medium Height Tissue Expander Style 6200, 650cc
• 00081317002277: SITLEX Medium Height Tissue Expander Style 6200, 550cc
• 00081317002260: SITLEX Medium Height Tissue Expander Style 6200, 450cc
• 00081317002253: SITLEX Medium Height Tissue Expander Style 6200, 350cc
• 00081317002246: SITLEX Medium Height Tissue Expander Style 6200, 275cc
• 00081317002239: SILTEX Low Height Tissue Expander Style 6100, 750cc
• 00081317002222: SILTEX Low Height Tissue Expander Style 6100, 650cc
• 00081317002215: SILTEX Low Height Tissue Expander Style 6100, 550cc
• 00081317002208: SILTEX Low Height Tissue Expander Style 6100, 450cc
• 00081317002192: SILTEX Low Height Tissue Expander Style 6100, 350cc
• 00081317002185: SILTEX Low Height Tissue Expander Style 6100, 250cc