OPEL-L 900-429-00

GUDID 07640332477519

OPEL-L IVIEW INLINE INSERTER

SpineArt SA

General internal orthopaedic fixation system implantation kit
Primary Device ID07640332477519
NIH Device Record Key71d0c532-b082-4b14-bb87-f980db9a00fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPEL-L
Version Model Number900-429-00
Catalog Number900-429-00
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
GS107640332477519 [Primary]

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


[07640332477519]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-28
Device Publish Date2025-11-20

On-Brand Devices [OPEL-L]

07640332477755OPEL-L PLATE ASSEMBLY, L38
07640332477731OPEL-L PLATE ASSEMBLY, L36
07640332477717OPEL-L PLATE ASSEMBLY, L34
07640332477694OPEL-L PLATE ASSEMBLY, L32
07640332477670OPEL-L PLATE ASSEMBLY, L30
07640332477656OPEL-L PLATE ASSEMBLY, L28
07640332477618OPEL-L IVIEW PLATE ASSEMBLY, L38
07640332477588OPEL-L IVIEW PLATE ASSEMBLY, L32
07640332477571OPEL-L IVIEW PLATE ASSEMBLY, L30
07640332477519OPEL-L IVIEW INLINE INSERTER
07640332477441OPEL-L IVIEW MODULAR DRILL GUIDE
07640332477298OPEL-L IVIEW PLATE ASSEMBLY, L42
07640332477274OPEL-L IVIEW PLATE ASSEMBLY, L40
07640332477205OPEL-L PLATE ASSEMBLY, L42
07640332477199OPEL-L PLATE ASSEMBLY, L40

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