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Ent Mr8

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
ENT MR8 FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
BUR 1847B80SCT ENTMR8 CUT 8MM STD FDA UDI
Model / Reference
1847B80SCT FDA UDI
Description
BUR 1847B80SCT ENTMR8 CUT 8MM STD FDA UDI

Identifiers

Primary DI / UDI-DI
00763000753986 FDA UDI
510(k) Number
K183515 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 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

Yes

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

Ent 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 e2d82183-f1ff-458f-911e-c2dafdfc591b 35 fields · synced Jun 9, 2026