FDA.reportPublic FDA data

Midas Rex

Primary DI
00763000335786
Brand
Midas Rex
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
31TD3030
Device description
TOOL 31TD3030 LEGEND 3MMX30MM TWST DRILL
Published
2020-11-22
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202552000Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)2020-11-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000335786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000335786007630003357867630003357860763000335786

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
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09