NuCrani Large Plate

GUDID G28436102

The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

Neurovention LLC

Cranioplasty plate, alterable

• Primary Device ID: G28436102
• NIH Device Record Key: 74398f4d-317b-4807-90db-33c415914d9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuCrani Large Plate
• Version Model Number: 361-02
• Company DUNS: 074912476
• Company Name: Neurovention LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	G28436102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192162

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

Sterilization

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

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

[G28436102]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

Devices Manufactured by Neurovention LLC

• G2843520100 - Drill Bit: 2024-10-25 Drill Bit 1.7 mm, Single-Use
• G284241019 - Screw Torx Slot: 2022-09-19 Screw Torx Slot 2mm x 6 mm
• G28433302 - Screwdriver Bit Torx Slot: 2022-06-30 Screwdriver Bit Torx Slot, Single Use
• G28424101 - Screw Torx Slot: 2022-06-29 2mm x 6 mm
• G28433001 - NuCrani Small Plate: 2022-06-29 The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotom
• G28433301 - Screwdriver Bit Torx: 2022-06-29 Screwdriver Bit T4 Torx, Single Use
• G28435101 - Rescue Screw Torx Slot: 2022-06-29 2.3 mm x 6 mm
• G28435201 - Drill Bit: 2022-06-29 Drill Bit, 1.5 mm x 6 mmm, Single Use