Summa Orthopaedics System Surgical Instrument

GUDID 08806390885775

Jeil Medical Corporation

Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 08806390885775
• NIH Device Record Key: 6c09a151-2227-4508-90ae-2a676c8d5b34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics System Surgical Instrument
• Version Model Number: SO-111-229-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: false
• 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	08806390885775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191972

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

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

[08806390885775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [Summa Orthopaedics System Surgical Instrument]

• 08806390883702: SO-112-120
• 08806390883696: SO-111-067-5
• 08806390883689: SO-111-068-5
• 08806390883672: SO-113-HF-617
• 08806390883665: SO-111-098
• 08806390883658: SO-112-40-701
• 08806390876155: SO-111-260
• 08806390869027: SO-111-047
• 08806390868983: SO-111-125
• 08806390868976: SO-111-124
• 08806390868952: SO-111-046
• 08806390868044: SO-111-080
• 08806390865852: SO-111-059
• 08806390865845: SO-111-058
• 08806390865791: SO-111-068-4
• 08806390865296: SO-111-057
• 08806390865272: SO-111-068-2
• 08806390864084: SO-111-056
• 08806390864077: SO-111-055
• 08806390864060: SO-111-060
• 08806390863292: SO-111-100
• 08806390863285: SO-111-096
• 08806390863278: SO-111-089
• 08806390863254: SO-111-087
• 08806390863230: SO-111-068-3
• 08806390862677: SO-111-104-R2
• 08806390862660: SO-111-104-R
• 08806390862653: SO-111-104-L2
• 08806390862646: SO-111-104-L
• 08806390862615: SO-111-127
• 08806390886130: SO-112-129-7
• 08806390886123: SO-112-129-6
• 08806390886116: SO-112-129-5
• 08806390886109: SO-112-129-4
• 08806390886093: SO-112-129-3
• 08806390886086: SO-112-129
• 08806390885799: SO-111-230-R
• 08806390885782: SO-111-230-L
• 08806390885775: SO-111-229-R
• 08806390885768: SO-111-229-L
• 08806390885751: SO-111-228-R
• 08806390885744: SO-111-228-L
• 08806390885737: SO-111-227-R
• 08806390885720: SO-111-227-L
• 08806390885713: SO-111-226
• 08806390869492: SO-111-095-L
• 08806390869485: SO-111-095-R
• 08806390869478: SO-111-083-L
• 08806390869461: SO-111-083-R
• 08806390869454: SO-111-082-L