Summa Orthopaedics Humerus System Bone Plate

GUDID 08800089449361

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08800089449361
• NIH Device Record Key: 55277389-89af-43f0-9919-43ca94e27f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Humerus System Bone Plate
• Version Model Number: SO-35-PLHU-A01-R
• 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	08800089449361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230938

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

[08800089449361]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-03
• Device Publish Date: 2024-09-25

On-Brand Devices [Summa Orthopaedics Humerus System Bone Plate]

• 08806390867757: SO-35-PLHU-005-R
• 08806390867740: SO-35-PLHU-004-R
• 08806390867733: SO-35-PLHU-003-R
• 08806390867726: SO-35-PLHU-005-L
• 08806390867719: SO-35-PLHU-004-L
• 08806390867702: SO-35-PLHU-003-L
• 08800089449514: SO-35-PLHU-119-R
• 08800089449507: SO-35-PLHU-117-R
• 08800089449484: SO-35-PLHU-113-R
• 08800089449477: SO-35-PLHU-111-R
• 08800089449460: SO-35-PLHU-109-R
• 08800089449453: SO-35-PLHU-107-R
• 08800089449446: SO-35-PLHU-119-L
• 08800089449439: SO-35-PLHU-117-L
• 08800089449422: SO-35-PLHU-115-L
• 08800089449415: SO-35-PLHU-113-L
• 08800089449408: SO-35-PLHU-111-L
• 08800089449392: SO-35-PLHU-109-L
• 08800089449385: SO-35-PLHU-107-L
• 08800089449378: SO-35-PLHU-S01-R
• 08800089449361: SO-35-PLHU-A01-R
• 08800089449354: SO-35-PLHU-S01-L
• 08800089449347: SO-35-PLHU-A01-L
• 08800089449491: SO-35-PLHU-115-R