FDA.reportPublic FDA data

Midas Rex®

Primary DI
00613994486233
Brand
Midas Rex®
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
PC720
Device description
ADAPTER PC720 MR7 TRITON PNEUMATIC
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CANREGULATOR, PRESSURE, GAS CYLINDER
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1
HBBMotor, Drill, PneumaticNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090112000MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions2009-03-26HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994486233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994486233006139944862336139944862330613994486233

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, rotary, pneumaticA hand-held, pneumatically-powered device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. The device may be cannulated to enable use of a guidewire and may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
098308849
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000374730Midas Rex MR8CA8752021-05-21
00643169912205Midas Rex MR8CA8752019-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-SleevedDynarex CorporationCAN2026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-SleevedDynarex CorporationCAN2026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-SleevedDynarex CorporationCAN2026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-SleevedDynarex CorporationCAN2026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-SleevedDynarex CorporationCAN2026-10-23
06970966665688GENTEC®GENTEC(SHANGHAI)CORPORATIONCAN2026-10-16
00848530109455Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2026-07-23
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2026-03-09
00848530108168RegulatorsSunset Healthcare Solutions, Inc.CAN2026-02-02
00848530108120RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530108151RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530107765Repair PartsSunset Healthcare Solutions, Inc.CAN2025-11-24
00848530107413React Regulator ValveSunset Healthcare Solutions, Inc.CAN2025-09-17
20763000722313ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722337ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722399MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
20763000722429MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00848530106034Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
00848530106041Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08