MONDRIAN

GUDID 00841732166578

ZERO FORCE INSERTER

CTL Medical Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732166578
• NIH Device Record Key: 3ae0bc69-8ef7-457b-a14a-a095c135e22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONDRIAN
• Version Model Number: 120.7530
• Company DUNS: 080138504
• Company Name: CTL Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com
• Phone: 214-545-5820
• Email: schedule@ctlamedica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732166578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192863

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

[00841732166578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [MONDRIAN]

• 00841732130319: 127.1074
• 00841732130302: 127.1073
• 00841732130296: 127.1072
• 00841732130289: 127.1071
• 00841732130272: 127.1070
• 00841732130265: 127.1069
• 00841732130258: 127.1068
• 00841732130241: 127.1067
• 00841732130234: 127.0836
• 00841732130227: 127.0835
• 00841732130210: 127.0834
• 00841732130203: 127.0833
• 00841732130197: 127.0832
• 00841732130180: 127.0831
• 00841732130173: 127.0830
• 00841732130166: 127.0829
• 00841732130159: 127.0828
• 00841732130142: 127.0827
• 00841732130135: 127.0716
• 00841732130128: 127.0715
• 00841732130111: 127.0714
• 00841732130104: 127.0713
• 00841732130098: 127.0712
• 00841732130081: 127.0711
• 00841732130074: 127.0710
• 00841732130067: 127.0709
• 00841732130050: 127.0708
• 00841732130043: 127.0707
• 00841732130593: 127.0873
• 00841732130586: 127.0872
• 00841732130579: 127.0871
• 00841732130562: 127.0870
• 00841732130555: 127.0869
• 00841732130548: 127.0868
• 00841732130531: 127.0867
• 00841732130524: 127.0756
• 00841732130517: 127.0755
• 00841732130500: 127.0754
• 00841732130494: 127.0753
• 00841732130487: 127.0752
• 00841732130470: 127.0751
• 00841732130463: 127.0750
• 00841732130456: 127.0749
• 00841732130449: 127.0748
• 00841732130432: 127.0747
• 00841732130425: 127.1196
• 00841732130418: 127.1195
• 00841732130401: 127.1194
• 00841732130395: 127.1193
• 00841732130388: 127.1192