SEURAT

GUDID 00841732129948

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732129948
• NIH Device Record Key: e4d3b6e0-b4dc-4613-812d-ec42ff7cbd8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEURAT
• Version Model Number: 126.2056
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732129948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173185

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

[00841732129948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-02
• Device Publish Date: 2021-05-25

On-Brand Devices [SEURAT]

• 00841732129986: 126.2251
• 00841732129979: 126.2246
• 00841732129962: 126.2241
• 00841732129955: 126.2061
• 00841732129948: 126.2056
• 00841732129931: 126.2051
• 00841732129924: 126.2046
• 00841732129917: 126.2041
• 00841732129900: 126.2036
• 00841732129894: 126.1861
• 00841732129887: 126.1856
• 00841732129870: 126.1851
• 00841732129863: 126.1846
• 00841732129856: 126.1841
• 00841732129849: 126.1836
• 00841732129832: 126.1656
• 00841732129825: 126.1651
• 00841732129818: 126.1646
• 00841732129801: 126.1641
• 00841732129795: 126.1636