FDA.report

Midas Rex

Primary DI
00763000245801
Brand
Midas Rex
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
BM200
Device description
BONE MILL BM200 LEGEND PNEU DISPOSABLE A^
Published
2022-04-03
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
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications

CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000245801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000245801007630002458017630002458010763000245801

GMDN Terms

TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000732974MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18
00763000865634MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2023-12-01
00763000732868MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2023-05-27
00763000521615MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-11-27
00763000521639MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-11-27
00763000521660MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-11-27
00763000651138MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-08-26
00763000651145MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-08-26
00763000595258Midas Rex™ MR8™MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-08-25
00763000595289Midas Rex™ MR8™MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-08-25
00763000595302Midas Rex™ MR8™MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-08-25
00763000545062MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-06-02
00763000545093MIDAS REX MICROSAWSMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-06-02
00763000453893MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-04-07
00763000454647MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-04-07
00763000245788Midas RexMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-04-04
00763000454852MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454869MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454876MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454890MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454906MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454913MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454920MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454937MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14
00763000454944MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2022-03-14