Silicone Sizer Set for ePTFE Premaxillary ESPM-SIZ-NS

GUDID M724ESPMSIZNS1

Silicone Sizer Set for ePTFE Premaxillary

IMPLANTECH ASSOCIATES, INC.

Nasal implant, synthetic polymer, non-bioabsorbable
Primary Device IDM724ESPMSIZNS1
NIH Device Record Key80ed0328-394f-47ee-a43e-25bf60aea2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Sizer Set for ePTFE Premaxillary
Version Model NumberESPM-SIZ
Catalog NumberESPM-SIZ-NS
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 Datefalse
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
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
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
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
HIBCCM724ESPMSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZEProsthesis, Nose, Internal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


[M724ESPMSIZNS1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-24
Device Publish Date2019-06-14

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 Top2024-11-11 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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