Neuro Plating System

GUDID 08809416061832

Burr Hole Plate, Long, 6Hole

OSTEONIC CO.,Ltd.

Cranioplasty plate, non-alterable

• Primary Device ID: 08809416061832
• NIH Device Record Key: fac5fde5-aff6-429b-9f68-c3893390fd98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Plating System
• Version Model Number: NBP304L06A
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• 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: true
• 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
GS1	08809416061832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141911

FDA Product Code

• HBW: Fastener, Plate, Cranioplasty

Sterilization

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

[08809416061832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-05
• Device Publish Date: 2019-02-13

On-Brand Devices [Neuro Plating System]

• 08809595972721: 3D Mesh Plate(200*200mm/0.6t)
• 08809595973049: ALU Tray coated with PU (body + drawer + Lid)
• 08809595973025: Forceps
• 08809595973018: Hand Driver (Small)
• 08809595973001: Hand Driver (Big)
• 08809595972998: 1x Magazine + 1x Cover + 6x Rescue screws 6mm
• 08809595972981: 1x Magazine + 1x Cover + 6x Rescue screws 4mm
• 08809595972974: 1x Magazine + 1x Cover + 6x Screws 5mm
• 08809595972967: 1x Magazine + 1x Cover + 6x Screws 3mm
• 08809595972950: 1x Screw disk + 100 screws 4mm
• 08809595972820: 10x Rescue screws 6mm
• 08809595972806: 10x Rescue screws 4mm
• 08809595972783: 10 x screws 5mm
• 08809595972769: 10 x screws 3mm
• 08809595972745: 10 x screws 4mm
• 08809595972714: 3D Mesh Plate(150*150mm/0.6t)
• 08809595972707: 3D Mesh Plate(50*50mm/0.6t)
• 08809595972691: Temporal Mesh Plate (42.2*25.1mm/0.4t)
• 08809539699820: IOC-141
• 08809539699691: ALU Tray oxidized (body + drawer + lid)
• 08809416061917: Burr Hole Calvarium Plate, Long, 6Hole
• 08809416061900: Burr Hole Calvarium Plate, Middle, 6Hole
• 08809416061887: Burr Hole Plate Slot, Extra, 5Hole
• 08809416061870: Burr Hole Plate Slot, Long, 5Hole
• 08809416061863: Burr Hole Plate Slot, Middle, 5Hole
• 08809416061856: Burr Hole Plate Slot, Short, 5Hole
• 08809416061849: Burr Hole Plate, Extra, 6Hole
• 08809416061832: Burr Hole Plate, Long, 6Hole
• 08809416061825: Burr Hole Plate, Middle, 6Hole
• 08809416061818: Burr Hole Plate, Short, 6Hole
• 08809416061801: Gap Plate, Long, 6Hole
• 08809416061795: Gap Plate, Middle, 6Hole
• 08809416061788: Gap Plate, Short, 6Hole
• 08809416061733: Y-Plate, Middle, 5Hole
• 08809416061726: Matrix Plate, Long, 8Hole
• 08809416061719: Matrix Plate, Middle, 8Hole
• 08809416061702: Double Square Plate, Middle, 6Hole
• 08809416061696: Rectangular Plate, Middle, 4Hole
• 08809416061689: Square Plate, Extra Long, 4Hole
• 08809416061672: Square Plate, Long, 4Hole
• 08809416061665: Square Plate, Middle, 4Hole
• 08809416061658: X-Plate, Middle, 4Hole
• 08809416061641: D-Y Plate, Long, 6Hole
• 08809416061634: D-Y Plate, Middle, 6Hole
• 08809416061627: Straight Plate, Middle, 20Hole
• 08809416061603: Straight Plate, Middle, 10Hole
• 08809416061580: Straight Plate, Middle, 6Hole
• 08809416061573: Straight Plate, Middle, 5Hole
• 08809416061566: Straight Plate, Extra, 4Hole
• 08809416061559: Straight Plate, Middle, 4Hole