Tray SF Push-in Anchor Portfolio T04-003

GUDID 07649990202365

Tray SF Push-in Anchor Portfolio

Surgical Fusion Technologies GmbH

Instrument tray, reusable
Primary Device ID07649990202365
NIH Device Record Key29451b53-b06c-4fe0-b0c9-a0733045e1c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTray SF Push-in Anchor Portfolio
Version Model NumberTray SF Push-in Anchor Portfolio
Catalog NumberT04-003
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com
Phone+41442046018
Emailcomplaints@surgical-fusion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107649990202365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


[07649990202365]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-22
Device Publish Date2024-04-12

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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