VALEO II

GUDID 00841732129412

Valeo II PL Trial 9x25mm 9° 8mm

CTL MEDICAL CORPORATION

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00841732129412
• NIH Device Record Key: 41aa8568-50fe-4bc2-a83d-7719a21152c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALEO II
• Version Model Number: 037.7028
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732129412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121892

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

[00841732129412]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [VALEO II]

• 00841732144811: VALEO II AL 39x30, 13, 12deg
• 00841732144804: VALEO II AL 39x30, 14, 12deg
• 00841732144460: VALEO II C 16x14, 6deg, 6mm
• 00841732144439: VALEO II PL 9x21mm, 0deg, 10mm
• 00841732144415: VALEO II PL 9x21mm, 0deg, 9mm
• 00841732144392: VALEO II PL 9x21mm, 0deg, 8mm
• 00841732144354: VALEO II PL 9x21mm, 0deg, 7mm
• 00841732144798: VALEO II AL 39x30, 15, 12deg
• 00841732144781: VALEO II AL 39x30, 17, 12deg
• 00841732144774: VALEO II LL 18x50x10mm, 6deg
• 00841732144767: VALEO II LL 18x55x10mm, 6deg
• 00841732144750: VALEO II LL 18x55x16mm, 6deg
• 00841732144743: VALEO II LL 22x50x10, 6deg
• 00841732144736: VALEO II LL 22x50x12mm, 6deg
• 00841732144729: VALEO II LL 22x55x10mm, 6deg
• 00841732144712: VALEO II LL 22x55x14mm, 6deg
• 00841732144705: VALEO II LL 22x60x10mm, 6deg
• 00841732144699: VALEO II LL 22x60x14mm, 6deg
• 00841732144682: VALEO II TL 6deg, 10x27, 9mm
• 00841732144675: VALEO II TL 6deg, 10x27, 10mm
• 00841732144668: VALEO II TL 6deg, 10x33, 10mm
• 00841732144651: VALEO II TL 6deg, 10x33, 11mm
• 00841732144613: VALEO II PL 9x21mm, 0deg, 11mm
• 00841732144606: VALEO II PL 9x21mm, 6deg, 11mm
• 00841732144590: VALEO II PL 9x21mm, 6deg, 12mm
• 00841732144583: VALEO II PL 9x25mm, 0deg, 7mm
• 00841732144576: VALEO II PL 9x25mm, 0deg, 8mm
• 00841732144569: VALEO II PL 9x25mm, 0deg, 9mm
• 00841732144552: VALEO II PL 9x25mm, 0deg, 12mm
• 00841732144538: VALEO II PL 9x25mm, 6deg, 12mm
• 00841732144514: VALEO II PL 9x25mm, 15deg, 14mm
• 00841732144507: VALEO II OL 9x32mm, 0deg, 12mm
• 00841732144491: VALEO II PL 11x25, 0deg, 7mm Flat
• 00841732160224: Valeo II PL 11x25 5° 16mm Flat
• 00841732156036: Valeo II OL 11x30 0° 10mm Flat
• 00841732156029: Valeo II OL 11x30 0° 9mm Flat
• 00841732156012: Valeo II OL 11x30 0° 8mm Flat
• 00841732156005: Valeo II OL 11x30 0° 7mm Flat
• 00841732155602: Valeo II PL 11x25 5° 15mm Flat
• 00841732155596: Valeo II PL 11x25 5° 14mm Flat
• 00841732155589: Valeo II PL 11x25 5° 13mm Flat
• 00841732155572: Valeo II PL 11x25 5° 12mm Flat
• 00841732155565: Valeo II PL 11x25 5° 11mm Flat
• 00841732155558: Valeo II PL 11x25 5° 10mm Flat
• 00841732155541: Valeo II PL 11x25 5° 9mm Flat
• 00841732155534: Valeo II PL 11x25 5° 8mm Flat
• 00841732155527: Valeo II PL 11x25 0° 16mm Flat
• 00841732155510: Valeo II PL 11x25 0° 15mm Flat
• 00841732155503: Valeo II PL 11x25 0° 14mm Flat
• 00841732155497: Valeo II PL 11x25 0° 9mm Flat