FDA.reportPublic FDA data

Midas Rex™

Primary DI
00643169797086
Brand
Midas Rex™
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
235GH1SS
Device description
BLADE 235GH1SS TRITON 5MM GRAFT HARVEST
Published
2016-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KFKSAW, PNEUMATICALLY POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFKSaw, Pneumatically PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870157000OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.1987-02-24KFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169797086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169797086006431697970866431697970860643169797086

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098308849
Device count
1
Lot or batch
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
10845854013298CONMEDConmed CorporationKFK2021-10-05
10845854023600CONMEDConmed CorporationKFK2021-10-05
20845854013219CONMEDConmed CorporationKFK2020-09-24
10845854013267CONMEDConmed CorporationKFK2020-09-24
10845854023617CONMEDConmed CorporationKFK2020-09-24
30845854013216NAConmed CorporationKFK2020-09-24
00643169797208Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-13
00643169797253Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-06
00643169797130Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797147Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797154Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797161Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797178Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797185Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797192Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797215Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797222Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797239Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797246Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797260Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797277Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797284Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797291Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797307Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797314Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797321Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797338Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169796911Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796928Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796935Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31