MR8

Primary DI
00763000865641
Brand
MR8
Company
MEDTRONIC ABLATION FRONTIERS, LLC
Model
MR8-23TD3010
Device description
TOOL MR8-23TD3010 MR8 23CM TWSTDRL3X10MM
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBBMOTOR, DRILL, PNEUMATIC
HBCMOTOR, DRILL, ELECTRIC
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HSZInstrument, surgical, orthopedic, pneumatic powered & accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBBMotor, Drill, PneumaticNeurology2
HBCMotor, Drill, ElectricNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183515000MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions2019-05-12HBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000865641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000865641007630008656417630008656410763000865641

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
159933634
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000865658MR8MR8-31TD30102023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-07-08
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504019NASTRYKER CORPORATIONERL2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
07613327504057NASTRYKER CORPORATIONERL2021-07-08
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2021-05-21
00763000216719CD HORIZON® SOLERA® VOYAGER™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HBE2020-12-31
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2019-06-08
10887587057026NASynthes GmbHHBE2019-02-22