FDA.reportPublic FDA data

NuGraf

Primary DI
B946069000040
Brand
NuGraf
Company
Nutech Spine, Inc.
Model
IR
Catalog number
06.900.004
Device description
NuGraf Cotton Sizer, 8.5mm
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B946069000040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080867996
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B946NF10050NuFixIRNF-10052020-09-24
B946NFII5000NuFix II01NFII-5002020-09-24
B946NFII500IR0NuFix IIIRNFII-5002020-09-24
B946011000010NuFix0401.100.0012024-07-15
B946007020010SIFixIR00.702.0012023-11-16
B946037000020SIFix0103.700.0022023-11-16
B946NF10090NuFixIRNF-10092020-09-24
B946008010040NuTech SpineIR00.801.0042020-09-24
B946014000010NuFix0101.400.0012020-09-24
B946021000010NuFix IIIR02.100.0012020-09-24
B946024000010NuFix IIIR02.400.0012020-09-24
B946024000030NuFix IIIR02.400.0032020-09-24
B946024000040NuFix IIIR02.400.0042020-09-24
B946024000050NuFix IIIR02.400.0052020-09-24
B946024000060NuFix IIIR02.400.0062020-09-24
B946024000070NuFix IIIR02.400.0072020-09-24
B946031000020SIFix0103.100.0022020-09-24
B946031002600SIFix0103.100.2602020-09-24
B946031100010SIFix0103.110.0012020-09-24
B946032000010SIFix0103.200.0012020-09-24

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Primary DI, Brand, Company table
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B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
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