Identity
- Trade Name
- Indigo™ FDA UDI
- Generic Name
- Surgical power tool system control unit, pneumatic FDA UDI
- Device Name
- DRILL 1845000 INDIGO HIGH SPD OTOL ROHS FDA UDI
- Model / Reference
- 1845000 FDA UDI
- Description
- DRILL 1845000 INDIGO HIGH SPD OTOL ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994933713 FDA UDI
- 510(k) Number
- K081277 FDA UDI
- FDA Product Code
- HBE FDA UDIHWE FDA UDIHRX FDA UDIHBC FDA UDIERL FDA UDI
- GMDN Term
- Surgical power tool system control unit, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI878.4820 FDA UDI888.1100 FDA UDI882.4360 FDA UDI874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical power tool system control unit, pneumatic
Indigo™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system control unit, pneumatic.
- Triton® — Medtronic Powered Surgical Solutions · Class I
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- Triton® — Medtronic Powered Surgical Solutions · Class I
- MIDAS REX — Medtronic Powered Surgical Solutions · Class II
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- MIDAS REX STEALTH-MIDAS MR8 — Medtronic Powered Surgical Solutions · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Cleared under the same submission
K081277 also covers:
- IPC Visao® — MEDTRONIC XOMED, INC.
- IPC™ Visao® — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Midas Rex Clearview — MEDTRONIC XOMED, INC.
- Midas Rex Clearview — MEDTRONIC XOMED, INC.
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 c2626240-5109-46c3-8460-2d3a512ac676 35 fields · synced May 30, 2026