NITINEX SI-1010

GUDID 00841731137340

NITINEX Staple Implant System, 10mm x 10mm, Sterile

VILEX LLC

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00841731137340
• NIH Device Record Key: 3b775987-6727-457b-8aab-3ff3b51a2a62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITINEX
• Version Model Number: SI-1010
• Catalog Number: SI-1010
• Company DUNS: 117502293
• Company Name: VILEX 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00841731137340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231493

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [NITINEX]

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• 00841731139948: NITINEX Implant Surgical Kit, 22mm x 22mm, Sterile
• 00841731139931: NITINEX Implant Surgical Kit, 20mm x 20mm, Sterile
• 00841731139924: NITINEX Implant Surgical Kit, 18mm x 18mm, Sterile
• 00841731139917: NITINEX Implant Surgical Kit, 15mm x 15mm, Sterile
• 00841731139900: NITINEX Implant Surgical Kit, 12mm x 12mm, Sterile
• 00841731139894: NITINEX Implant Surgical Kit, 10mm x 10mm, Sterile
• 00841731139887: NITINEX Implant Surgical Kit, 8mm x 8mm, Sterile
• 00841731139566: NITINEX Staple Implant Sizer Assembly, Sterile
• 00841731138019: NITINEX Staple Implant System, 18mm x 18mm, Sterile
• 00841731137531: NITINEX Staple Implant System, 30mm x 30mm, Sterile
• 00841731137500: NITINEX Staple Implant System, 25mm x 25mm, Sterile
• 00841731137463: NITINEX Staple Implant System, 22.5mm x 22.5mm, Sterile
• 00841731137432: NITINEX Staple Implant System, 20mm x 20mm, Sterile
• 00841731137371: NITINEX Staple Implant System, 15mm x 15mm, Sterile
• 00841731137357: NITINEX Staple Implant System, 12mm x 12mm, Sterile
• 00841731137340: NITINEX Staple Implant System, 10mm x 10mm, Sterile
• 00841731137326: NITINEX Staple Implant System, 8mm x 8mm, Sterile