Smoke Aspiration Tip SE-100

GUDID M724SE100102

Smoke Aspiration Tip

IMPLANTECH ASSOCIATES, INC.

Surgical plume evacuation system tube
Primary Device IDM724SE100102
NIH Device Record Key776ea660-3b4e-4f68-b6b9-f5e9e8f04811
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmoke Aspiration Tip
Version Model NumberSE-100
Catalog NumberSE-100
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
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
HIBCCM724SE1001 [Primary]
HIBCCM724SE100102 [Package]
Contains: M724SE1001
Package: Box [10 Units]
In Commercial Distribution
HIBCCM724SE100252 [Package]
Contains: M724SE1001
Package: Box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-06
Device Publish Date2021-07-29

Devices Manufactured by IMPLANTECH ASSOCIATES, INC.

M724ESL58501 - Solid ePTFE Nasal L Implant2024-11-11 Solid ePTFE Nasal L Implant
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)

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