FDA.report

Midas Rex

Primary DI
00763000245818
Brand
Midas Rex
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
BM210
Device description
BONE MILL BM210 LEGEND ELEC DISPOSABLE
Published
2022-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYSBone mill

Product Code Classifications

CodeDeviceSpecialtyClass
LYSBone MillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000245818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000245818007630002458187630002458180763000245818

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
098308849
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00199150001989MR8MR8-15MH20L2026-03-09
00763000521622MIDAS REX MR8MR8-ASDS01-R2025-08-10
00763000980849Reservoir24106 A2025-08-03
00763000980856Reservoir22101 A2025-07-31
00763000722326ENT MR81847CVTUBEA2025-07-25
00763000722340ENT MR81847IRTUBEA2025-07-25
00763000722364MIDAS REX MICROSAWSIRD4102025-07-25
00763000722388MIDAS REX LEGENDIRD4502025-07-25
00763000722319ENT MR81847CVTUBBX2025-07-25
00763000722333ENT MR81847IRTUBBX2025-07-25
00763000722357MIDAS REX LEGENDIRD4002025-07-25
00763000722401MIDAS REX MR8IRD8502025-07-21
00763000722418MIDAS REX MR8IRD8702025-07-21
00763000722395MIDAS REX MR8IRD8002025-07-21
00763000722425MIDAS REX MR8IRD8752025-07-21
00763000988784Midas Rex MR8MR8-14MH30F2025-07-17
00763000988791Midas Rex MR8MR8-14MH30X2025-07-17
00721902573613MIDAS REXEM2002025-03-27
00763000651169Midas Rex MR8MR8-9AC60M2025-03-22
00763000521813MIDAS REX LEGENDPC2302025-03-20

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00889024675360Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
B504BMBM2100MedtronicProvisionLYS2024-06-11
04047844121368DIPLOMATSIGNUS Medizintechnik GmbHLYS2024-06-05
00842517106253Karl SchumacherKarl Schumacher Dental, LLCLYS2024-02-27
10603295516378NADEPUY ORTHOPAEDICS, INC.LYS2024-01-15
00614950031252ACEACE SURGICAL SUPPLY CO., INC.LYS2023-12-05
00888118142924BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142931BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142948BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142955BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142962BONE MILLKLS-Martin L.P.LYS2023-11-22
00841336103399Salvin Bone Morselizer With Titanium Knurled SurfacesSalvin Dental Specialties, Inc.LYS2023-08-10
00841336103504Salvin Titanium Bone Cruncher™Salvin Dental Specialties, Inc.LYS2023-08-10
00888118142597BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142603BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142610BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142627BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142634BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142641BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142658BONE MILLKLS-Martin L.P.LYS2023-07-04
00190776264055AvalignAVALIGN TECHNOLOGIES, INC.LYS2023-06-23
08720254007816Sterilization tray NBMSpierings Orthopaedics B.V.LYS2023-06-20
08720254007823HousingSpierings Orthopaedics B.V.LYS2023-06-20
08720254007830Push BlockSpierings Orthopaedics B.V.LYS2023-06-20
08720254007847HandleSpierings Orthopaedics B.V.LYS2023-06-20
08720254007854Screw nutSpierings Orthopaedics B.V.LYS2023-06-20
08720254007861Milling Drum Extra Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20