FDA.reportPublic FDA data

Midas Rex®

Primary DI
00613994486219
Brand
Midas Rex®
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
PC700
Device description
ACCY PC700 MR7 FOOT CRTL 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
HBBMOTOR, DRILL, PNEUMATIC
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HSZInstrument, surgical, orthopedic, pneumatic powered & accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

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
00613994486219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994486219006139944862196139944862190613994486219

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, pneumaticA pneumatically-powered (gas-powered) component of a surgical power tool system intended to regulate the gas pressure supplied to the pneumatic handpiece/motor (not included) and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

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
Serial number
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
00816589021615Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
00816589021622Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
04546540246332NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246356NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246387NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246974NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246981NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540251862NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356499NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356505NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356512NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356529NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356536NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356543NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356567NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366467NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366481NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366498NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366504NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366511NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540366528NAStryker Leibinger GmbH & Co. KGHBE2016-08-24