Z-Handle

GUDID 04057217005874

Z-Medical GmbH + Co. KG

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID04057217005874
NIH Device Record Key9dca77bc-4d7f-4e2d-9955-f12b6952aa5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-Handle
Version Model NumberA16 909
Company DUNS332068761
Company NameZ-Medical GmbH + Co. KG
Device Count1
DM Exemptfalse
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 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+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de
Phone+497462945540
Emailinfo@z-medical.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104057217005874 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


[04057217005874]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

Devices Manufactured by Z-Medical GmbH + Co. KG

04057217000015 - Z-Pedicle Screw2024-04-09
04057217000022 - Z-Pedicle Screw2024-04-09
04057217000039 - Z-Pedicle Screw2024-04-09
04057217000046 - Z-Pedicle Screw2024-04-09
04057217000053 - Z-Pedicle Screw2024-04-09
04057217000060 - Z-Pedicle Screw2024-04-09
04057217000077 - Z-Pedicle Screw2024-04-09
04057217000084 - Z-Pedicle Screw2024-04-09

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