CLEARFIX RIGID STERNAL FIXATION Bone Screw

GUDID 08800089436620

Jeil Medical Corporation

Sternal fixation device

• Primary Device ID: 08800089436620
• NIH Device Record Key: 73993069-3924-46f8-841e-2089a4145b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIX RIGID STERNAL FIXATION Bone Screw
• Version Model Number: CF-24L-SA-S16-TA
• 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	08800089436620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181806

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

Moist Heat or Steam Sterilization

[08800089436620]

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 Screw]

• 08800089436712: CF-27L-SA-S20-TA
• 08800089436705: CF-27L-SA-S18-TA
• 08800089436699: CF-27L-SA-S16-TA
• 08800089436682: CF-27L-SA-S14-TA
• 08800089436675: CF-27L-SA-S12-TA
• 08800089436668: CF-27L-SA-S10-TA
• 08800089436651: CF-27L-SA-S08-TA
• 08800089436644: CF-24L-SA-S20-TA
• 08800089436637: CF-24L-SA-S18-TA
• 08800089436620: CF-24L-SA-S16-TA
• 08800089436613: CF-24L-SA-S14-TA
• 08800089436606: CF-24L-SA-S12-TA
• 08800089436590: CF-24L-SA-S10-TA
• 08800089436583: CF-24L-SA-S08-TA