PowerFlex™ Plus Pectoral Implant Sizer HTPI-2L-SIZ-NS

GUDID M724HTPI2LSIZNS1

Pectoral Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724HTPI2LSIZNS1
• NIH Device Record Key: 8234961c-6ff0-4627-8cba-46884017e41a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerFlex™ Plus Pectoral Implant Sizer
• Version Model Number: HTPI / Size 2/ Left
• Catalog Number: HTPI-2L-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	M724HTPI2LSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952708

FDA Product Code

• MIC: Implant, Muscle, Pectoralis

Sterilization

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

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

Moist Heat or Steam Sterilization

[M724HTPI2LSIZNS1]

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

On-Brand Devices [PowerFlex™ Plus Pectoral Implant Sizer]

• M724HTPI2RSIZNS1: Pectoral Implant Sizer
• M724HTPI2LSIZNS1: Pectoral Implant Sizer