icotec Systems, Handle, 1/4" Coupling 42-892

GUDID 07640172553848

icotec Systems, Handle, 1/4" Coupling

icotec AG

Surgical instrument handle, non-torque-limiting
Primary Device ID07640172553848
NIH Device Record Key528ea2d6-a06c-4cea-a25d-2b336d46ea22
Commercial Distribution StatusIn Commercial Distribution
Brand Nameicotec Systems, Handle, 1/4" Coupling
Version Model Number42-892
Catalog Number42-892
Company DUNS480789465
Company Nameicotec AG
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+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172553848 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

[07640172553848]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-21
Device Publish Date2025-08-13

Devices Manufactured by icotec AG

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07640172552551 - CMORE® System, Pedicle Probe, Straight2025-12-02 CMORE® System, Pedicle Probe, Straight
07640172552568 - CMORE® System, Drill Guide Sleeve2025-12-02 CMORE® System, Drill Guide Sleeve
07640172552575 - CMORE® System, Drill Guide Stop2025-12-02 CMORE® System, Drill Guide Stop
07640172552582 - CMORE® System, Drill Bit, Ø 2.3 mm2025-12-02 CMORE® System, Drill Bit, Ø 2.3 mm
07640172552599 - CMORE® System, Feeler2025-12-02 CMORE® System, Feeler
07640172552605 - CMORE® System, In-line Handle, AO Coupling2025-12-02 CMORE® System, In-line Handle, AO Coupling
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