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Mr8

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
MR8 FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
TOOL MR8-SD12BA40DC MR8 12CM SD B DC4MM FDA UDI
Model / Reference
MR8-SD12BA40DC FDA UDI
Description
TOOL MR8-SD12BA40DC MR8 12CM SD B DC4MM FDA UDI

Identifiers

Primary DI / UDI-DI
00763000732998 FDA UDI
510(k) Number
K183515 FDA UDI
FDA Product Code
HBE FDA UDI
ERL FDA UDI
HSZ FDA UDI
HBC FDA UDI
HBB FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
874.4250 FDA UDI
878.4820 FDA UDI
882.4360 FDA UDI
882.4370 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: Orthopaedic bur, single-use

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

Similar devices

Also classified as Orthopaedic bur, single-use.

Cleared under the same submission

K183515 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Powered Surgical Solutions

Sources (1)

  • FDA UDI dc64e3e4-7e41-463a-b399-e4a403cb4f67 35 fields · synced Jun 9, 2026