FDA.reportPublic FDA data

HiCUT Burs

Primary DI
04251388960097
Brand
HiCUT Burs
Company
adeor Medical AG
Model
4.8 mm balltip, MR conditional
Catalog number
B48MR
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253772000Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG2026-03-06HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251388960097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251388960097042513889600974251388960097

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond 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 soft or hard skull tissue. This is a single-use device.

Regulatory Flags#

DUNS number
341188943
Device count
1
Lot or batch
true
Expiration date on label
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
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
04251388941102PMT Drill Cutter2.1mmx254mm(10in.)2103-1182025-04-25

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