Sonotrode PI-S 2.3 S04-001

GUDID 07649990202037

Surgical Fusion Technologies GmbH

Ultrasonic surgical system generator
Primary Device ID07649990202037
NIH Device Record Key617bcdcf-b00e-41e5-aac8-af759ef07ce2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonotrode PI-S 2.3
Version Model NumberSonotrode PI-S 2.3
Catalog NumberS04-001
Company DUNS482948937
Company NameSurgical Fusion Technologies GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com
Phone+41 442046018
Emailcomplaints@surgical-fusion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107649990202037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


[07649990202037]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-22
Device Publish Date2023-12-14

Devices Manufactured by Surgical Fusion Technologies GmbH

07649990202419 - Drill S-PI-A1.6 extra short2026-01-26 Drill extra short for SF Push-in Anchor 1.6
07649990202020 - Tray_SF Push-In Anchor 2.32024-11-29 Tray SF Push-in Anchor 2.3
07649990202075 - SupraFuser Generator2024-04-22
07649990202228 - SF Push-in Anchor 1.62024-04-22
07649990202235 - SF Push-in Anchor 3.02024-04-22
07649990202259 - Stopper S-PI-A1.62024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 1.6
07649990202266 - Stopper S-PI-A2.32024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 2.3
07649990202273 - Stopper S-PI-A3.02024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 3.0

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