MENTOR Diaphragm Valve Fill Tube 600975-001

GUDID 00081317004561

DV Fill Tube

MENTOR TEXAS L.P.

Saline-filled breast implant, unstructured

• Primary Device ID: 00081317004561
• NIH Device Record Key: 0a9c6e7b-02af-437e-a59e-c153ea4a5c7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR Diaphragm Valve Fill Tube
• Version Model Number: 600975-001
• Catalog Number: 600975-001
• 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: false
• 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	00081317004561 [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

Devices Manufactured by MENTOR TEXAS L.P.

• 10081317032332 - MENTOR CPX4 PLUS Enhance, Smooth, Tall Height: 2025-04-03 Breast Tissue Expander, Suture Tabs, Integral Injection Dome
• 10081317028670 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 225cc
• 10081317028687 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 250cc
• 10081317028694 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 275cc
• 10081317028700 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 300cc
• 10081317028717 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 325cc
• 10081317028724 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 350cc
• 10081317028731 - MENTOR Smooth Round Moderate Plus Profile: 2025-03-25 Saline Breast Implant, 375cc