Silicone Sizer Set for ePTFE Midfacial ESMF-SIZ-NS

GUDID M724ESMFSIZNS1

Silicone Sizer Set for ePTFE Midfacial

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis

• Primary Device ID: M724ESMFSIZNS1
• NIH Device Record Key: 08cff5ff-55e2-4e46-9e9a-1fe1ef38e27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sizer Set for ePTFE Midfacial
• Version Model Number: ESMF-SIZ
• Catalog Number: ESMF-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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724ESMFSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141027

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

[M724ESMFSIZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-24
• Device Publish Date: 2019-06-14

Devices Manufactured by IMPLANTECH ASSOCIATES, INC.

• M724ESL58501 - Solid ePTFE Nasal L Implant: 2024-11-11 Solid ePTFE Nasal L Implant
• M724ESL62601 - Solid ePTFE Nasal L Implant: 2024-11-11 Solid ePTFE Nasal L Implant
• M724ESPF501 - Solid ePTFE Paranasal, Flat Top: 2024-11-11 Solid ePTFE Paranasal, Flat Top
• M724ESPF701 - Solid ePTFE Paranasal, Flat Top: 2024-11-11 Solid ePTFE Paranasal, Flat Top
• M724ESPS501 - Solid ePTFE Paranasal, Sharp Top: 2024-11-11 Solid ePTFE Paranasal, Sharp Top
• M724EST52501 - Solid ePTFE Nasal Dorsum, T Implant: 2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
• M724EST58501 - Solid ePTFE Nasal Dorsum, T Implant: 2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
• M724CCB64SIZNS1 - ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop): 2024-05-29 ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)