Neuro Plating System

GUDID 08809416061832

Burr Hole Plate, Long, 6Hole

OSTEONIC CO.,Ltd.

Cranioplasty plate, non-alterable
Primary Device ID08809416061832
NIH Device Record Keyfac5fde5-aff6-429b-9f68-c3893390fd98
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Plating System
Version Model NumberNBP304L06A
Company DUNS688999370
Company NameOSTEONIC CO.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809416061832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFastener, Plate, Cranioplasty

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809416061832]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-05
Device Publish Date2019-02-13

On-Brand Devices [Neuro Plating System]

088095959727213D Mesh Plate(200*200mm/0.6t)
08809595973049ALU Tray coated with PU (body + drawer + Lid)
08809595973025Forceps
08809595973018Hand Driver (Small)
08809595973001Hand Driver (Big)
088095959729981x Magazine + 1x Cover + 6x Rescue screws 6mm
088095959729811x Magazine + 1x Cover + 6x Rescue screws 4mm
088095959729741x Magazine + 1x Cover + 6x Screws 5mm
088095959729671x Magazine + 1x Cover + 6x Screws 3mm
088095959729501x Screw disk + 100 screws 4mm
0880959597282010x Rescue screws 6mm
0880959597280610x Rescue screws 4mm
0880959597278310 x screws 5mm
0880959597276910 x screws 3mm
0880959597274510 x screws 4mm
088095959727143D Mesh Plate(150*150mm/0.6t)
088095959727073D Mesh Plate(50*50mm/0.6t)
08809595972691Temporal Mesh Plate (42.2*25.1mm/0.4t)
08809539699820IOC-141
08809539699691ALU Tray oxidized (body + drawer + lid)
08809416061917Burr Hole Calvarium Plate, Long, 6Hole
08809416061900Burr Hole Calvarium Plate, Middle, 6Hole
08809416061887Burr Hole Plate Slot, Extra, 5Hole
08809416061870Burr Hole Plate Slot, Long, 5Hole
08809416061863Burr Hole Plate Slot, Middle, 5Hole
08809416061856Burr Hole Plate Slot, Short, 5Hole
08809416061849Burr Hole Plate, Extra, 6Hole
08809416061832Burr Hole Plate, Long, 6Hole
08809416061825Burr Hole Plate, Middle, 6Hole
08809416061818Burr Hole Plate, Short, 6Hole
08809416061801Gap Plate, Long, 6Hole
08809416061795Gap Plate, Middle, 6Hole
08809416061788Gap Plate, Short, 6Hole
08809416061733Y-Plate, Middle, 5Hole
08809416061726Matrix Plate, Long, 8Hole
08809416061719Matrix Plate, Middle, 8Hole
08809416061702Double Square Plate, Middle, 6Hole
08809416061696Rectangular Plate, Middle, 4Hole
08809416061689Square Plate, Extra Long, 4Hole
08809416061672Square Plate, Long, 4Hole
08809416061665Square Plate, Middle, 4Hole
08809416061658X-Plate, Middle, 4Hole
08809416061641D-Y Plate, Long, 6Hole
08809416061634D-Y Plate, Middle, 6Hole
08809416061627Straight Plate, Middle, 20Hole
08809416061603Straight Plate, Middle, 10Hole
08809416061580Straight Plate, Middle, 6Hole
08809416061573Straight Plate, Middle, 5Hole
08809416061566Straight Plate, Extra, 4Hole
08809416061559Straight Plate, Middle, 4Hole

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