Summa Orthopaedics Wrist System Bone Plate

GUDID 08806390886048

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390886048
• NIH Device Record Key: f2d8a5d0-b420-4c9a-ad43-2e66a32ebc66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Wrist System Bone Plate
• Version Model Number: SO-25R-DVRA-209-L
• 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	08806390886048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191972

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390886048]

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 Wrist System Bone Plate]

• 08806390876988: SO-25-DVRA-310-L
• 08806390876971: SO-25-DVRA-310-R
• 08806390876964: SO-25-DVRA-210-L
• 08806390876957: SO-25-DVRA-210-R
• 08806390876940: SO-25-DVRA-110-L
• 08806390876933: SO-25-DVRA-110-R
• 08806390869430: SO-25-DVRA-311-L
• 08806390869423: SO-25-DVRA-311-R
• 08806390869416: SO-25-DVRA-309-L
• 08806390869409: SO-25-DVRA-309-R
• 08806390869393: SO-25-DVRA-211-L
• 08806390869386: SO-25-DVRA-211-R
• 08806390869379: SO-25-DVRA-209-L
• 08806390869362: SO-25-DVRA-209-R
• 08806390869355: SO-25-DVRA-111-L
• 08806390869348: SO-25-DVRA-111-R
• 08806390869331: SO-25-DVRA-109-L
• 08806390869324: SO-25-DVRA-109-R
• 08806390886079: SO-25R-DVRA-211-R
• 08806390886062: SO-25R-DVRA-211-L
• 08806390886055: SO-25R-DVRA-209-R
• 08806390886048: SO-25R-DVRA-209-L
• 08806390886031: SO-25R-DVRA-110-R
• 08806390886024: SO-25R-DVRA-110-L
• 08806390886017: SO-25R-DVRA-108-R
• 08806390886000: SO-25R-DVRA-108-L
• 08806390885881: SO-25J-DVRA-211-R
• 08806390885874: SO-25J-DVRA-211-L
• 08806390885867: SO-25J-DVRA-209-R
• 08806390885850: SO-25J-DVRA-209-L
• 08806390885843: SO-25J-DVRA-110-R
• 08806390885836: SO-25J-DVRA-110-L
• 08806390885829: SO-25J-DVRA-108-R
• 08806390885812: SO-25J-DVRA-108-L
• 08806390868013: SO-25-CAFU-006
• 08806390868006: SO-25-CAFU-007
• 08806390862479: SO-25V-DLUL-107-H3
• 08806390862462: SO-25V-DLUL-107-H2
• 08806390862455: SO-25V-DLUL-106-H2
• 08806390862448: SO-25V-DLUL-007-H3
• 08806390862431: SO-25V-DLUL-007-H2
• 08806390862424: SO-25V-DLUL-006-H2