MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZ-MHB-400S

GUDID 10081317031458

Moderate High Profile BOOST, For Use With SMHB-400

MENTOR TEXAS L.P.

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• Primary Device ID: 10081317031458
• NIH Device Record Key: 50908a4e-cdf9-4b3f-a623-213a8b6df022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENTOR MemoryGel BOOST Resterilizable Gel Sizer
• Version Model Number: RSZMHB400S
• Catalog Number: RSZ-MHB-400S
• 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: false
• 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
• Phone: +1(800)235-5731
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10081317031458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062421

FDA Product Code

• MRD: Mammary sizer

Sterilization

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

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

[10081317031458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

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• 00081317027300: Moderate Plus Profile BOOST, For Use With SMPB-530
• 00081317027294: Moderate Plus Profile BOOST, For Use With SMPB-480
• 00081317027287: Moderate Plus Profile BOOST, For Use With SMPB-450
• 00081317027270: Moderate Plus Profile BOOST, For Use With SMPB-430
• 00081317027263: Moderate Plus Profile BOOST, For Use With SMPB-390
• 00081317027256: Moderate Plus Profile BOOST, For Use With SMPB-340
• 00081317027249: Moderate Plus Profile BOOST, For Use With SMPB-320
• 00081317027232: Moderate Plus Profile BOOST, For Use With SMPB-290
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• 00081317027195: Moderate Plus Profile BOOST, For Use With SMPB-185
• 00081317027188: Moderate Plus Profile BOOST, For Use With SMPB-160
• 00081317027171: Moderate Plus Profile BOOST, For Use With SMPB-130
• 10081317031526: Moderate High Profile BOOST, For Use With SMHB-775
• 10081317031519: Moderate High Profile BOOST, For Use With SMHB-700
• 10081317031502: Moderate High Profile BOOST, For Use With SMHB-635
• 10081317031496: Moderate High Profile BOOST, For Use With SMHB-580
• 10081317031489: Moderate High Profile BOOST, For Use With SMHB-500
• 10081317031472: Moderate High Profile BOOST, For Use With SMHB-470
• 10081317031465: Moderate High Profile BOOST, For Use With SMHB-435
• 10081317031458: Moderate High Profile BOOST, For Use With SMHB-400
• 10081317031441: Moderate High Profile BOOST, For Use With SMHB-375
• 10081317031434: Moderate High Profile BOOST, For Use With SMHB-355
• 10081317031427: Moderate High Profile BOOST, For Use With SMHB-330
• 10081317031410: Moderate High Profile BOOST, For Use With SMHB-310
• 10081317031403: Moderate High Profile BOOST, For Use With SMHB-280
• 10081317031397: Moderate High Profile BOOST, For Use With SMHB-260
• 10081317031380: Moderate High Profile BOOST, For Use With SMHB-230