900-004 Articulated Chin Sizer Set 900-004

GUDID M7249000041

Chin Sizer Set

IMPLANTECH ASSOCIATES, INC.

Chin prosthesis Chin prosthesis Chin prosthesis Chin prosthesis Chin prosthesis Chin prosthesis Chin prosthesis Chin prosthesis
Primary Device IDM7249000041
NIH Device Record Key95bab100-4a5a-4c5b-8f6b-a0e0ff8edc9a
Commercial Distribution StatusIn Commercial Distribution
Brand Name900-004 Articulated Chin Sizer Set
Version Model Number900-004
Catalog Number900-004
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7249000041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWPProsthesis, Chin, Internal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


[M7249000041]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-28
Device Publish Date2021-07-20

Devices Manufactured by IMPLANTECH ASSOCIATES, INC.

M724ANI010NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI020NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI030NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI031NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI040NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI0411 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANI041NS1 - Anatomical Nasal Implant2024-03-05 Nasal Implant
M724ANISIZNS1 - Anatomical Implant Nasal Sizers2024-03-05 Anatomical Implant Nasal Sizers

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.