Valeo II LL

GUDID 00841732167339

T-HANDLE WITH COMFORT SILICONE GRIP, HUDSON ADAPTER

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit
Primary Device ID00841732167339
NIH Device Record Key2f30479c-543c-4071-ad51-d3114f4089f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameValeo II LL
Version Model Number31-5500-002
Company DUNS080138504
Company NameCTL Medical Corporation
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com
Phone214-545-5820
Emailschedule@ctlamedica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732167339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841732167339]

Moist Heat or Steam Sterilization


[00841732167339]

Moist Heat or Steam Sterilization


[00841732167339]

Moist Heat or Steam Sterilization


[00841732167339]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-19
Device Publish Date2024-12-11

On-Brand Devices [Valeo II LL]

00841732128729042.7700
00841732167322Valeo II LL Extractor
00841732165236VALEO II LL Slap Hammer Adapter
00841732158672K Wire
00841732158665Blade Extension, Trocar
00841732158658Blade Extension, Shim
00841732167339T-HANDLE WITH COMFORT SILICONE GRIP, HUDSON ADAPTER

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