Summa Orthopaedics Clavicle System Bone Plate

GUDID 08806390874960

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390874960
• NIH Device Record Key: 8f95b7ac-f9db-49cf-9f47-072865526b09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Clavicle System Bone Plate
• Version Model Number: SO-35-SMCL-009-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	08806390874960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180972

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

[08806390874960]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-06-04
• Device Publish Date: 2018-11-15

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

• 08806390875226: SO-35-HPCL-008-L2
• 08806390875219: SO-35-HPCL-007-L2
• 08806390875202: SO-35-HPCL-006-L2
• 08806390875196: SO-35-HPCL-005-L2
• 08806390875189: SO-35-HPCL-008-L5
• 08806390875172: SO-35-HPCL-007-L5
• 08806390875165: SO-35-HPCL-005-L5
• 08806390875158: SO-35-HPCL-008-L8
• 08806390875141: SO-35-HPCL-007-L8
• 08806390875134: SO-35-HPCL-006-L8
• 08806390875127: SO-35-HPCL-005-L8
• 08806390875110: SO-35-SLCL-009-R
• 08806390875103: SO-35-SLCL-008-R
• 08806390875097: SO-35-SLCL-007-R
• 08806390875080: SO-35-SLCL-006-R
• 08806390875073: SO-35-SLCL-005-R
• 08806390875066: SO-35-SLCL-004-R
• 08806390875059: SO-35-SLCL-009-L
• 08806390875042: SO-35-SLCL-008-L
• 08806390875035: SO-35-SLCL-007-L
• 08806390875028: SO-35-SLCL-006-L
• 08806390875011: SO-35-SLCL-005-L
• 08806390875004: SO-35-SLCL-004-L
• 08806390874991: SO-35-SMCL-010-RI
• 08806390874984: SO-35-SMCL-008-RI
• 08806390874977: SO-35-SMCL-010-R
• 08806390874960: SO-35-SMCL-009-R
• 08806390874953: SO-35-SMCL-008-R
• 08806390874946: SO-35-SMCL-007-R
• 08806390874939: SO-35-SMCL-006-R
• 08806390874922: SO-35-SMCL-010-LI
• 08806390874915: SO-35-SMCL-008-LI
• 08806390874908: SO-35-SMCL-010-L
• 08806390874892: SO-35-SMCL-009-L
• 08806390874885: SO-35-SMCL-008-L
• 08806390874878: SO-35-SMCL-007-L
• 08806390874861: SO-35-SMCL-006-L
• 08806390875424: SO-35-HPCL-006-L5
• 08806390875349: SO-35-HPCL-008-R2
• 08806390875332: SO-35-HPCL-007-R2
• 08806390875325: SO-35-HPCL-006-R2
• 08806390875318: SO-35-HPCL-005-R2
• 08806390875301: SO-35-HPCL-008-R5
• 08806390875295: SO-35-HPCL-007-R5
• 08806390875288: SO-35-HPCL-006-R5
• 08806390875271: SO-35-HPCL-005-R5
• 08806390875264: SO-35-HPCL-008-R8
• 08806390875257: SO-35-HPCL-007-R8
• 08806390875240: SO-35-HPCL-006-R8
• 08806390875233: SO-35-HPCL-005-R8