Solid ePTFE Paranasal, Sharp Top ES-PS-50

GUDID M724ESPS501

Solid ePTFE Paranasal, Sharp Top

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724ESPS501
NIH Device Record Keyd0ad5dba-0999-4391-acc8-decc7c03e657
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolid ePTFE Paranasal, Sharp Top
Version Model NumberSize: 5mm
Catalog NumberES-PS-50
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724ESPS501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZKImplant, Malar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-11
Device Publish Date2024-11-01

Devices Manufactured by IMPLANTECH ASSOCIATES, INC.

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M724ESL62601 - Solid ePTFE Nasal L Implant2024-11-11 Solid ePTFE Nasal L Implant
M724ESPF501 - Solid ePTFE Paranasal, Flat Top2024-11-11 Solid ePTFE Paranasal, Flat Top
M724ESPF701 - Solid ePTFE Paranasal, Flat Top2024-11-11 Solid ePTFE Paranasal, Flat Top
M724ESPS501 - Solid ePTFE Paranasal, Sharp Top2024-11-11Solid ePTFE Paranasal, Sharp Top
M724ESPS501 - Solid ePTFE Paranasal, Sharp Top2024-11-11 Solid ePTFE Paranasal, Sharp Top
M724EST52501 - Solid ePTFE Nasal Dorsum, T Implant2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
M724EST58501 - Solid ePTFE Nasal Dorsum, T Implant2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
M724CCB64SIZNS1 - ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)2024-05-29 ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)

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