CLEARFIX RIGID STERNAL FIXATION Bone Plate

GUDID 08800089436491

Jeil Medical Corporation

Sternal fixation device

• Primary Device ID: 08800089436491
• NIH Device Record Key: 94e1eed4-2ab6-4d47-8569-bed32050d83e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIX RIGID STERNAL FIXATION Bone Plate
• Version Model Number: CF-24-LPST-004
• Company DUNS: 688811603
• Company Name: Jeil 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800089436491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181806

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

[08800089436491]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-17
• Device Publish Date: 2023-03-09

On-Brand Devices [CLEARFIX RIGID STERNAL FIXATION Bone Plate]

• 08800089436576: CF-24-HNST-012
• 08800089436569: CF-24-HWST-012
• 08800089436552: CF-24-JLST-008
• 08800089436545: CF-24-XPST-008
• 08800089436538: CF-24-STST-008
• 08800089436521: CF-24-STST-004
• 08800089436514: CF-24-HSST-008
• 08800089436507: CF-24-SQST-004
• 08800089436491: CF-24-LPST-004