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Indigo™

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
Indigo™ FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
BUR 31131084 INDIGO RND FINE DMND 1.0MM FDA UDI
Model / Reference
31131084 FDA UDI
Description
BUR 31131084 INDIGO RND FINE DMND 1.0MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169591165 FDA UDI
510(k) Number
K111520 FDA UDI
FDA Product Code
HBE FDA UDI
ERL FDA UDI
GMDN Term
Orthopaedic bur, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
874.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.0 Millimeter FDA UDI

Category: Orthopaedic bur, reusable

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

Similar devices

Also classified as Orthopaedic bur, reusable.

Cleared under the same submission

K111520 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 ac467665-6693-4cda-8992-89bb7e3bccde 36 fields · synced Jun 9, 2026