PowerFlex™ Pectoral Implant Sizer BNPI2-1L-SIZ-NS

GUDID M724BNPI21LSIZNS1

Pectoral Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Pectoral implant, sterile

• Primary Device ID: M724BNPI21LSIZNS1
• NIH Device Record Key: 5ada0e5a-b277-43fa-9b82-2c2b3a08efc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerFlex™ Pectoral Implant Sizer
• Version Model Number: Novack Style 2 / Size 1/ Left
• Catalog Number: BNPI2-1L-SIZ-NS
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• 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: true
• Expiration Date: false
• 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: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724BNPI21LSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944163

FDA Product Code

• MIC: Implant, Muscle, Pectoralis

Sterilization

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

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

[M724BNPI21LSIZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-15
• Device Publish Date: 2022-02-07

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• M724BNPI21LSIZNS1: Pectoral Implant Sizer
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• M724ACPI42LSIZNS1: Pectoral Implant Sizer
• M724ACPI41RSIZNS1: Pectoral Implant Sizer
• M724ACPI41LSIZNS1: Pectoral Implant Sizer