NuCrani Small Plate

GUDID G28433001

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 Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable

• Primary Device ID: G28433001
• NIH Device Record Key: f62708a0-d0eb-4d80-b29c-bdde8c7329b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuCrani Small Plate
• Version Model Number: 330-01
• 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	G28433001 [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

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

Moist Heat or Steam Sterilization

[G28433001]

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

• 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: 2022-06-29The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
• 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
• G28435301 - Screwdriver: 2022-06-29 Screwdriver