Identity
- Trade Name
- Indigo™ FDA UDI
- Generic Name
- Metal/carbide ENT bur, single-use FDA UDI
- Device Name
- BUR 31312579 INDIGO RND STEEL CUT 2.5MM FDA UDI
- Model / Reference
- 31312579 FDA UDI
- Description
- BUR 31312579 INDIGO RND STEEL CUT 2.5MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169579248 FDA UDI
- 510(k) Number
- K081475 FDA UDI
- FDA Product Code
- ERL FDA UDIHBE FDA UDI
- GMDN Term
- Metal/carbide ENT bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI882.4310 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
Dimensions & Sizes
- Size
- Outer Diameter — 2.5 Millimeter FDA UDI
Category: Metal/carbide ENT bur, single-use
Indigo™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal/carbide ENT bur, single-use.
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- JEDMED — JEDMED Instrument Company · Class I
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- JEDMED — JEDMED Instrument Company · Class I
- OSSEOUS Burs-stainless Steel — EON MEDITECH PRIVATE LIMITED · Class I
- GYRUS ACMI — Gyrus Acmi, Inc. · Class I
- Bur PM2-95 80K Steel Ø1.8 St — Bien-Air Surgery SA · Class II
Cleared under the same submission
K081475 also covers:
- Indigo — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- MIDAS REX® — MEDTRONIC XOMED, INC.
- Midas Rex® — MEDTRONIC XOMED, INC.
- Midas Rex® — MEDTRONIC XOMED, INC.
- SKEETER® — MEDTRONIC XOMED, INC.
- Skeeter® — MEDTRONIC XOMED, INC.
- VISAO ™ — MEDTRONIC XOMED, INC.
- VISAO™ — MEDTRONIC XOMED, INC.
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX MICROSAWS — Medtronic Powered Surgical Solutions
- MIDAS REX MICROSAWS — Medtronic Powered Surgical Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 7c9aa24b-85a4-4479-8f4d-bb96d9fd4449 36 fields · synced May 30, 2026