FDA.reportPublic FDA data

MR8 Tools

Primary DI
00763000447281
Brand
MR8 Tools
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
MR8-12MH30SH
Device description
TOOL MR8-12MH30SH 12CM MATCH 3MM SHORT
Published
2023-05-11
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

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)
HXZCUTTER, WIRE

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
HXZCutter, WireOrthopedic1

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
00763000447281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000447281007630004472817630004472810763000447281

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
098308849
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000374976Midas Rex LegendPC7102020-10-02
00763000244859MIDAS REXPC710-R2019-07-19
00763000080174MIDAS REXPC7102019-06-08
00763000514006MIDAS REX MR8MR8-SP14MH302022-04-22
00199150001989MR8MR8-15MH20L2026-03-09
00763000545116MIDAS REX MR8IRD8502022-06-02
00763000545123MIDAS REX MR8IRD8702022-06-02
00763000487126MIDS REX MR8MR8-10BA30D2022-01-01
00763000753412ENT MR81847B20SDM2022-12-29
00763000514020MIDAS REX CURVED BURMR8-SP14MH30T2022-04-22
00763000753382ENT MR81847B20SCT2022-12-29
20763000545134ENT MR8IRD8752022-06-02
00763000030636N/A24106 A2020-04-19
00763000031107N/A22101 A2020-04-19
00643169497542NA24106 A2015-07-07
00643169579385NA22101 A2015-06-24
00613994908308NA24106 A2015-06-16
00613994908674NA22101 A2015-06-17
00763000521622MIDAS REX MR8MR8-ASDS01-R2025-08-10
20763000545103MIDAS REX MR8IRD8002022-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
10886982064721NASynthes GmbHHBE2016-06-30
10886982064721NASynthes GmbHERL2016-06-30
10886982064738NASynthes GmbHHBE2016-06-30
10886982064738NASynthes GmbHERL2016-06-30
10886982064745NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064745NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064820NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064820NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064844NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064844NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064882NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064882NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064905NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064905NASYNTHES (U.S.A.) LPHBE2016-06-30
10886982064912NASynthes GmbHERL2016-06-30
10886982064912NASynthes GmbHHBE2016-06-30