Handle with AO connection system

GUDID 08437019739324

Accessory handle used to insert instruments with AO connection.

ABANZA TECNOMED SL.

Surgical instrument handle, non-torque-limiting
Primary Device ID08437019739324
NIH Device Record Key4cad3433-a3d8-47e2-84d9-e4f8e05a4066
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandle with AO connection system
Version Model Number21
Company DUNS465714287
Company NameABANZA TECNOMED SL.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com
Phone(866) 550-7070
Emailcustomerservice@abanzamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108437019739324 [Primary]
GS128437019739328 [Package]
Package: Primary [1 Units]
In Commercial Distribution

FDA Product Code

GDZHandle, Scalpel

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


[08437019739324]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-09
Device Publish Date2023-06-01

Devices Manufactured by ABANZA TECNOMED SL.

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28437019739892 - WasherCap Mini Fixation system 3.5mm2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
28437019739908 - WasherCap Mini Fixation system 4.5mm2025-03-05 The WasherCap™ Mini Fixation System is a medical device designed for fixation of suture/tape (soft tissue) to bone during surg
08437019739812 - WasherCap™ Fixation System 7mm2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
08437019739829 - WasherCap™ Fixation System 8mm2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
08437019739836 - WasherCap™ Fixation System 9mm2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
08437019739843 - WasherCap™ Fixation System 10mm 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue
08437019739164 - WasherCap™ Screwdriver2023-06-09 Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap.

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