FDA.reportPublic FDA data

HiCUT Micro saw

Primary DI
04251388941874
Brand
HiCUT Micro saw
Company
adeor Medical AG
Model
sagittal 10 mm
Catalog number
VMN-S-10-S
Published
2021-06-11
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130755000HICUT HIGHSPEED INSTRUMENTAdeor Medical AG2014-06-27HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251388941874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251388941874042513889418744251388941874

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.

Sterilization Methods#

Method table
Method

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
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

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Primary DI, Brand, Company table
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07630055505774PM PERFOBien-Air Surgery SAHBE2023-02-09
07630055505798NANO CableBien-Air Surgery SAHBE2023-02-09
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