← Back to catalogue

Midas Rex Mr8

FDA UDI

Class I (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
MIDAS REX MR8 FDA UDI
Generic Name
Surgical irrigation tubing set, single-use FDA UDI
Device Name
TUBING IRD850 MR8 IRRIGATION ON-DRILL EA FDA UDI
Model / Reference
IRD850 FDA UDI
Description
TUBING IRD850 MR8 IRRIGATION ON-DRILL EA FDA UDI

Identifiers

Primary DI / UDI-DI
00763000545116 FDA UDI
510(k) Number
K183515 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Surgical irrigation tubing set, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical irrigation tubing set, single-use

Midas Rex Mr8 by Medtronic Powered Surgical Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation tubing set, single-use.

Cleared under the same submission

K183515 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Powered Surgical Solutions

Sources (1)

  • FDA UDI 2bb71465-dc5e-49ac-af8a-4b2596d39236 35 fields · synced Jun 9, 2026