Smoke Aspiration Tip SE-100

GUDID M724SE100102

Smoke Aspiration Tip

IMPLANTECH ASSOCIATES, INC.

Surgical plume evacuation system tube

• Primary Device ID: M724SE100102
• NIH Device Record Key: 776ea660-3b4e-4f68-b6b9-f5e9e8f04811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smoke Aspiration Tip
• Version Model Number: SE-100
• Catalog Number: SE-100
• 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: 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: 1-800-733-0833
• 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
• 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	M724SE1001 [Primary]
HIBCC	M724SE100102 [Package]; Contains: M724SE1001; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M724SE100252 [Package]; Contains: M724SE1001; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931548

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-06
• Device Publish Date: 2021-07-29

Devices Manufactured by IMPLANTECH ASSOCIATES, INC.

• M724CCB64SIZNS1 - ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop): 2024-05-29 ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)
• M724CCB5SIZ5NS1 - ContourFlex™ Gluteal Implant Sizer Round: 2024-05-28 ContourFlex™ Gluteal Implant Sizer Round
• M724CCB5SIZ6NS1 - ContourFlex™ Gluteal Implant Sizer Round: 2024-05-28 ContourFlex™ Gluteal Implant Sizer Round
• M724CCB5SIZ0NS1 - ContourFlex™ Gluteal Implant Sizer: 2024-05-21 ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ1NS1 - ContourFlex™ Gluteal Implant Sizer: 2024-05-21 ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ2NS1 - ContourFlex™ Gluteal Implant Sizer: 2024-05-21 ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ3NS1 - ContourFlex™ Gluteal Implant Sizer: 2024-05-21 ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ4NS1 - ContourFlex™ Gluteal Implant Sizer: 2024-05-21 ContourFlex™ Gluteal Implant Sizer