KONG-C VBR System, KONG-C VBR M, Container, complete 43-090

GUDID 07640172550076

KONG-C VBR System, KONG-C VBR M, Container, complete

icotec AG

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID07640172550076
NIH Device Record Keyb7e31d73-f706-4219-b7f1-da004661e90a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKONG-C VBR System, KONG-C VBR M, Container, complete
Version Model Number43-090
Catalog Number43-090
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 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+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
Phone+41717570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172550076 [Primary]

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


[07640172550076]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-18
Device Publish Date2023-09-08

Devices Manufactured by icotec AG

07640164846675 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm
07640164846804 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm
07640164846880 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm
07640164848785 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm
07640164848792 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm
07640164848808 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm
07640164848815 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm
07640164848822 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm

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