10 x 50mm SI Fusion Fastener Cann Sterile 202-10050-S

GUDID 00810097801356

10 x 50mm SI Fusion Fastener Cann Sterile

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

• Primary Device ID: 00810097801356
• NIH Device Record Key: 344dd139-2bb3-407f-8c09-93cd297f528b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10 x 50mm SI Fusion Fastener Cann Sterile
• Version Model Number: 202-10050-S
• Catalog Number: 202-10050-S
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC LLC
• 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: false
• 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 Dimensions

• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097801356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161755

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-25
• Device Publish Date: 2022-08-17

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