Identity
- Trade Name
- MIDAS REX MR8 FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- TUBING IRD870 MR8 CLEARVIEW EA FDA UDI
- Model / Reference
- IRD870 FDA UDI
- Description
- TUBING IRD870 MR8 CLEARVIEW EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000722418 FDA UDI
- 510(k) Number
- K183515 FDA UDI
- FDA Product Code
- HBE FDA UDIERL FDA UDIHBC FDA UDIHBB FDA UDIHXZ FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI874.4250 FDA UDI882.4360 FDA UDI882.4370 FDA UDI888.4540 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: Surgical irrigation tubing set, single-use
Midas Rex Mr8 by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical irrigation tubing set, single-use.
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- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
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- AESCULAP — AESCULAP, INC. · Class II
Cleared under the same submission
K183515 also covers:
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- MIDAS REX — Medtronic Powered Surgical Solutions
- MIDAS REX MR8 — 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 Powered Surgical Solutions
Sources (1)
- FDA UDI 1ff4b7c5-3d70-450f-9b4e-97c34c48bb33 35 fields · synced Jun 9, 2026