NOVA Minimally Invasive System

GUDID 04712899252793

Pre-Bent Rod

BAUI BIOTECH CO. LTD.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID04712899252793
NIH Device Record Keyb905befd-465f-4c02-ae43-bcfd03108c2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA Minimally Invasive System
Version Model Number320-5512C
Company DUNS656775504
Company NameBAUI BIOTECH CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104712899252793 [Primary]
GS104712899252793 [Primary]
GS104712899252793 [Primary]
GS104712899252793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System
NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04712899252793]

Moist Heat or Steam Sterilization


[04712899252793]

Moist Heat or Steam Sterilization


[04712899252793]

Moist Heat or Steam Sterilization


[04712899252793]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [NOVA Minimally Invasive System]

04718005156344Poly Axial Screw
04718005156337Poly Axial Screw
04718005156320Poly Axial Screw
04718005156313Poly Axial Screw
04718005156306Poly Axial Screw
04718005156290Poly Axial Screw
04718005156283Poly Axial Screw
04718005156276Poly Axial Screw
04718005156269Poly Axial Screw
04718005156252Poly Axial Screw
04718005156245Poly Axial Screw
04718005156238Poly Axial Screw
04718005156221Poly Axial Screw
04718005156214Poly Axial Screw
04718005156207Poly Axial Screw
04718005156191Poly Axial Screw
04718005156184Poly Axial Screw
04718005156177Poly Axial Screw
04718005156160Poly Axial Screw
04718005156153Poly Axial Screw
04718005156146Poly Axial Screw
04718005156139Poly Axial Screw
04718005156122Poly Axial Screw
04718005156115Poly Axial Screw
04718005156108Poly Axial Screw
04718005156092Poly Axial Screw
04718005156467Poly Axial Screw
04718005156450Poly Axial Screw
04718005156443Poly Axial Screw
04718005156436Poly Axial Screw
04718005156429Poly Axial Screw
04718005156412Poly Axial Screw
04718005156405Poly Axial Screw
04718005156399Poly Axial Screw
04718005156382Poly Axial Screw
04718005156375Poly Axial Screw
04718005156368Poly Axial Screw
04718005156351Poly Axial Screw
04718005156849Poly Axial Screw
04718005156832Poly Axial Screw
04718005156825Poly Axial Screw
04718005156818Poly Axial Screw
04718005156801Poly Axial Screw
04718005156795Poly Axial Screw
04718005156788Poly Axial Screw
04718005156771Poly Axial Screw
04718005156764Poly Axial Screw
04718005156757Poly Axial Screw
04718005156740Poly Axial Screw
04718005156733Poly Axial Screw

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