FDA.reportPublic FDA data

Midas Rex

Primary DI
20763000374833
Brand
Midas Rex
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
PA305
Device description
ACCY PA305 MIDAS REX SM CLEANING BRSH PK
Published
2020-10-02
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
GEEBRUSH, BIOPSY, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEEBrush, Biopsy, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020069000MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex2002-03-18HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000374833PrimaryGS10
00763000374839Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300037483320763000374833
00763000374839007630003748397630003748390763000374839

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
098308849
Device count
5
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
00850068304851SBHSBH SurgicalGEE2026-05-08
00190776420970MillenniumAvalign Technologies, Inc.GEE2026-04-30
00860011506348SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00860011506355SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00816207021720Biopsy BrushENDO-THERAPEUTICS, INC.GEE2025-02-26
06971317521769StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
06971317521776StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521766StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521773StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
00190776300708MillenniumAvalign Technologies, Inc.GEE2023-11-15
00190776301637MillenniumAvalign Technologies, Inc.GEE2023-11-15
00816207021027Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021041Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021690Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021706Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021713Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00190776198176MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198183MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198190MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198206MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198213MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198220MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198237MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198244MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198251MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198268MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198275MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198282MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198299MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198305MillenniumAvalign Technologies, Inc.GEE2021-11-02