SMARTbuilder System

GUDID 08800000921136

Osstem Implant Co., Ltd.

Extra-gynaecological surgical mesh, metal Extra-gynaecological surgical mesh, metal Extra-gynaecological surgical mesh, metal Extra-gynaecological surgical mesh, metal Extra-gynaecological surgical mesh, metal Extra-gynaecological surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal Dental/maxillofacial surgical mesh, metal

• Primary Device ID: 08800000921136
• NIH Device Record Key: 34550c3a-b2db-4c6d-99c6-c04e607c12c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTbuilder System
• Version Model Number: SM1W4109SB
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08800000921136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120951

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2015-10-14

On-Brand Devices [SMARTbuilder System]

• 08800000920993: SMHA443
• 08800000920986: SMHA443R
• 08800000920979: SMHA444
• 08800000920962: SMHA444R
• 08800000920955: SMHA553R
• 08800000920948: SMHA554R
• 08800000920931: SMHA663W
• 08800000920924: SMHA664W
• 08800000920917: SMHA773W
• 08800000920900: SMHA774W
• 08800000961286: SM1W487SB
• 08800000921143: SM1W4107SB
• 08800000921136: SM1W4109SB
• 08800000921129: SM1W487SB
• 08800000921112: SM2W10127SB
• 08800000921105: SM2W10129SB
• 08800000921099: SM2W12127SB
• 08800000921082: SM2W12129SB
• 08800000921075: SM2W797SB
• 08800000921068: SM2W799SB
• 08800000921051: SM3W10127SB
• 08800000921044: SM3W10129SB
• 08800000921037: SM3W12127SB
• 08800000921020: SM3W12129SB
• 08800000921013: SM3W797SB
• 08800000921006: SM3W799SB
• 08809917096357: SMHI420E
• 08809917096326: SMHI415E
• 08809917096296: SMHI410E
• 08809917096289: SMHI405E
• 08809917096128: SMHA554R
• 08809917096111: SMHA553R
• 08809917096104: SMHA444
• 08809917096098: SMHA444R
• 08809917096081: SMHA443
• 08809917096074: SMHA443R