INLET Sternal System Bone Plate

GUDID 08800089411184

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089411184
• NIH Device Record Key: f5aee5ea-d12e-44dd-bb46-56c6f128c060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET Sternal System Bone Plate
• Version Model Number: IN24-HSST-008
• 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	08800089411184 [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

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

[08800089411184]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [INLET Sternal System Bone Plate]

• 08800089411191: IN24-HNST-012
• 08800089411184: IN24-HSST-008
• 08800089411177: IN24-HWST-012
• 08800089411160: IN24-JLST-008
• 08800089411153: IN24-LPST-004
• 08800089411146: IN24-SQST-004
• 08800089411139: IN24-STST-004
• 08800089411122: IN24-STST-008
• 08800089411115: IN24-XPST-008