FDA.reportPublic FDA data

VELOCITY ALPHA ™

Primary DI
04251388957134
Brand
VELOCITY ALPHA ™
Company
adeor Medical AG
Model
minimally invasive attachment 120 mm straight
Catalog number
VMN-TS2
Published
2021-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191479000Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG2021-04-11HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251388957134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251388957134042513889571344251388957134

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, line-poweredAn assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
341188943
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251388961278PMT Drill Cutter 2.2 x 20 mm2103-2542026-04-02
04251388960530VELOCITY ALPHA ™MR conditional Nitrogen DISS female hand tight x 1DA-15UN-M2-DH2026-03-31
04251388910801VELOCITY ALPHA ™Foot control, pneumatic (MR conditional)ZMF-1502026-03-30
04251388924105VELOCITY ALPHA ™Wall-Tubing, open-end, (MR conditional)ZMW-1212026-03-30
04251388959954VELOCITY ALPHA ™straight nosepiece short, MR conditionalVMN-S1-MR2026-03-30
04251388959961VELOCITY ALPHA ™angled nosepiece XXL, MR conditionalVMN-A5-MR2026-03-30
04251388959978VELOCITY ALPHA ™Highspeed motor pneumatic, MR conditional 80.000 rZMM-100-MR2026-03-30
04251388960080HiCUT Burs2.2 mm neuro Matchstick, MR conditionalN22MR2026-03-30
04251388960097HiCUT Burs4.8 mm balltip, MR conditionalB48MR2026-03-30
04251388960103HiCUT Burs3.4 mm drill, MR conditionalDR34MR2026-03-30
04251388960110HiCUT Burs4.5 mm drill, MR conditionalDR45MR2026-03-30
04251388960431VELOCITY ALPHA ™Steri-Tray made from plastic, custom made for MR cPST-MR2026-03-30
04251388960448VELOCITY ALPHA ™"Wall-Tubing, 1/8"" NPT connector, (MR conditionalZMW-1222026-03-30
04251388961001VELOCITY ALPHA ™Motor tube, straight, MR conditionalZMW-110-MR2026-03-30
04251388960387HiCUT Burs7.5 mm balltipB752025-04-30
04251388958315HiCUT Burs4.0 mm balltip, smooth cutB40S2025-04-29
04251388959855HiCUT Burs8.0 mm diamond ball standardDB802025-04-29
04251388959985HiCUT Burs3.2 mm balltip, smooth cutB32S2025-04-29
04251388959992HiCUT Burs5.0 mm balltip, smooth cutB50S2025-04-29
04251388960004HiCUT Burs6.0 mm balltip, smooth cutB60S2025-04-29

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