FDA.reportPublic FDA data

Surgify Halo 5.4 mm Long

Primary DI
06429811532106
Brand
Surgify Halo 5.4 mm Long
Company
Surgify Medical Oy
Model
54.125.NVG.H1
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06429811532106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06429811532106064298115321066429811532106

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
368510617
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06429811532205Surgify Halo 3.0 mm Short30.070.NVG.U22026-03-31
06429811532212Surgify Halo 3.0 mm Long30.125.NVG.U22026-03-31
06429811532229Surgify Halo 3.0 mm Extendable30.000.SEE.U22026-03-31
06429811532267Surgify Halo 4.0 mm Short40.070.NVG.U12026-03-31
06429811532274Surgify Halo 4.0 mm Long40.125.NVG.U12026-03-31
06429811532281Surgify Halo 4.0 mm Extendable40.000.SEE.U12026-03-31
06429811532298Surgify Halo 5.4 mm Short54.070.NVG.U12026-03-31
06429811532304Surgify Halo 5.4 mm Long54.125.NVG.U12026-03-31
06429811532311Surgify Halo 5.4 mm Extendable54.000.SEE.U12026-03-31
06429811532328Surgify Halo 5.4 mm Medium54.085.SHD.U12026-03-31
06429811532335Surgify Halo 5.4 mm Long54.140.SHD.U12026-03-31
06429811532069Surgify Halo 4.0 mm Short40.070.NVG.H12025-06-18
06429811532076Surgify Halo 4.0 mm Extendable40.000.SEE.H12025-06-18
06429811532083Surgify Halo 4.0 mm Long40.125.NVG.H12025-06-18
06429811532090Surgify Halo 5.4 mm Short54.070.NVG.H12025-04-02
06429811532120Surgify Halo 5.4 mm Medium54.085.SHD.H12025-04-02
06429811532137Surgify Halo 5.4 mm Long54.140.SHD.H12025-04-02
06429830116998Surgify Halo 5.4 mm Extendable54.000.SEE.H12025-04-02
06429830116943Surgify Halo - 5.4 mm - Medium100-54-TM (US)2024-12-20
06429830116950Surgify Halo - 5.4 mm - Long100-54-TL (US)2024-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBE2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBE2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBE2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SAHBE2023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SAHBE2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAHBE2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09