BAGUERA C INSTRUMENTATION CDP-IN 40 14-N

GUDID 07640139343154

Pins Ø 4.2 L14

SpineArt SA

Intraoperative bone pin/screw, non-sterile
Primary Device ID07640139343154
NIH Device Record Key8b444fee-053e-487a-859a-e6d142a5fcd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBAGUERA C INSTRUMENTATION
Version Model NumberCDP-IN 40 14-N
Catalog NumberCDP-IN 40 14-N
Company DUNS483016148
Company NameSpineArt SA
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640139343154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


[07640139343154]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-05
Device Publish Date2016-09-27

On-Brand Devices [BAGUERA C INSTRUMENTATION]

07640139343727Articulated Cervical distractor
07640139343192Nut for Pins
07640139343178Pins Ø 4.2 L18
07640139343161Pins Ø 4.2 L16
07640139343154Pins Ø 4.2 L14
07640139343147Pins Ø 4.2 L12
07640139343130Pins Ø 3.6 L16
07640139343123Pins Ø 3.6 L16
07640139343116Pins Ø 3.6 L14
07640139343109Pins Ø 3.6 L12
07640178983687ARTICULATED CERVICAL DISTRACTOR LEFT
07640178971189ADJUSTABLE STOP NUT
07640178971172ADJUSTABLE STOP NUT
07640305160202ADJUSTABLE STOP
07640139343086DISTRACTION FORCEPS
07640139343055IMPLANT HOLDER

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.