SMARTbuilder System (SB1)

GUDID 08800000925219

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: 08800000925219
• NIH Device Record Key: 1a1a7054-9609-4da3-968a-53f15a382120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTbuilder System (SB1)
• Version Model Number: SB1P103A
• 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	08800000925219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130840

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: 2015-10-16

On-Brand Devices [SMARTbuilder System (SB1)]

• 08800000925233: SB1P73A
• 08800000925226: SB1P75A
• 08800000925219: SB1P103A
• 08800000925202: SB1P105A
• 08800000925196: SB1P123A
• 08800000925189: SB1P125A
• 08800000925172: SM2W597SE
• 08800000925165: SM2W599SE
• 08800000925158: SM2W6127SE
• 08800000925141: SM2W6129SE
• 08800000925134: SM2W7127SE
• 08800000925127: SM2W7129SE