Silicone Sizer Set for ePTFE Nasal Dorsum, Rounded ESNR-SIZ-NS

GUDID M724ESNRSIZNS1

Silicone Sizer Set for ePTFE Nasal Dorsum, Rounded

IMPLANTECH ASSOCIATES, INC.

Nasal implant, synthetic polymer, non-bioabsorbable
Primary Device IDM724ESNRSIZNS1
NIH Device Record Keyf8c4ec3a-1dec-445f-aaf1-69a41b8a715c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Sizer Set for ePTFE Nasal Dorsum, Rounded
Version Model NumberESNR-SIZ
Catalog NumberESNR-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
HIBCCM724ESNRSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZEProsthesis, Nose, Internal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

Moist Heat or Steam Sterilization


[M724ESNRSIZNS1]

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.

M724NGBL20CVFNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Clear, Very Firm
M724NGBL20FFEZNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Fleshtone, Firm (EZ)
M724NGBL20FMEZNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Fleshtone, Medium (EZ)
M724NGBL20FSNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Fleshtone, Soft
M724NGBL20OVSNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Opaque, Very Soft
M724NGBL20RFM30EZNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Red Fleshtone Medium 30 (EZ)
M724NGBL20RFS15EZNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Red Fleshtone, Soft 15 (EZ)
M724NGBL20RFS20EZNS1 - Silicone Block 2.02025-09-04 Silicone Block 2.0, Red Fleshtone, Soft 20 (EZ)

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