4CIS® VANE Spine SYSTEM 4901-0078

GUDID 08806373590566

Guide Wire 1.1x480mm

SOLCO BIOMEDICAL CO.,LTD.

Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable
Primary Device ID08806373590566
NIH Device Record Key65bd82bd-a32a-4b34-9006-c6b4d3b4322c
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS® VANE Spine SYSTEM
Version Model Number4901-0078
Catalog Number4901-0078
Company DUNS687844241
Company NameSOLCO BIOMEDICAL CO.,LTD.
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
GS108806373590566 [Primary]

FDA Product Code

OWIBone Fixation Cerclage, Sublaminar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806373590566]

Moist Heat or Steam Sterilization


[08806373590566]

Moist Heat or Steam Sterilization


[08806373590566]

Moist Heat or Steam Sterilization


[08806373590566]

Moist Heat or Steam Sterilization


[08806373590566]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

On-Brand Devices [4CIS® VANE Spine SYSTEM]

08806373590566Guide Wire 1.1x480mm
08806373594366VP Needle 145.5mm

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