MENTOR Tissue Expander 3505303M

GUDID 00081317002567

Smooth Eliptical, 75cc

MENTOR TEXAS L.P.

Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander

• Primary Device ID: 00081317002567
• NIH Device Record Key: 30119c81-94c0-4ee8-8f45-0d9a9a94f2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Tissue Expander
• Version Model Number: 3505303M
• Catalog Number: 3505303M
• 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	00081317002567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842883

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: 2015-09-14

On-Brand Devices [MENTOR Tissue Expander]

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• 00081317002581: Smooth Eliptical, 250cc
• 00081317002574: Smooth Eliptical, 150cc
• 00081317002567: Smooth Eliptical, 75cc
• 00081317002550: Smooth Eliptical, 50cc
• 00081317002543: Smooth Eliptical, 25cc
• 00081317002536: Smooth Crescent, 500cc
• 00081317002529: Smooth Crescent, 400cc
• 00081317002512: Smooth Crescent, 300cc
• 00081317002505: Smooth Crescent, 200cc
• 00081317002499: Smooth Crescent, 100cc
• 00081317002482: Smooth Crescent, 50cc
• 00081317002475: Smooth Rectangle, 700cc
• 00081317002468: Smooth Rectangle, 550cc
• 00081317002451: Smooth Rectangle, 50cc
• 00081317002444: Smooth Round, 850cc
• 00081317002437: Smooth Round, 550cc
• 00081317002420: Smooth Round, 1000cc
• 00081317002413: Smooth Round, 400cc
• 00081317002406: Smooth Round, 700cc
• 00081317002390: Smooth Rectangle, 400cc
• 00081317002383: Smooth Rectangle, 250cc
• 00081317002376: Smooth Rectangle, 100cc