Midas Rex

Primary DI
00763000374839
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 brush/tool, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098308849
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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