FDA.reportPublic FDA data

Midas Rex®

Primary DI
20613994486206
Brand
Midas Rex®
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
PA700
Device description
ACCY PA700 LUBRICANT DIFFUSER MR7 4 PACK
Published
2016-04-30
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
20613994486206PrimaryGS10
00613994486202Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399448620620613994486206
00613994486202006139944862026139944862020613994486202

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool maintenance unitA device used for the automatic internal lubrication and maintenance of surgical power tools (e.g., pneumatically or electrically driven motors, turbines, or attachments). This device will automatically run programs for the lubrication of the internal components with service oil and flushing with compressed air after external cleansing, but prior to sterilization. This process is intended to improve performance and safety of the surgical instruments. The unit is designed to accept different handpieces which are connected directly or via adaptors to the unit's processing chamber.

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
4
Lot or batch
true
Sterilization required before use
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
04251388960530VELOCITY ALPHA ™adeor Medical AGHBB2026-03-31
04251388910801VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388924105VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959954VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959961VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959978VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388960448VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388961001VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2026-03-09
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
20763000722313ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722337ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722399MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
20763000722429MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000651169Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-22
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714604MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000714482MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714536MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-04-27
00763000732943MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18