Identity
- Trade Name
- Midas Rex FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- TRAY PA620 3/4 DIN INSTR CASE MR7 FDA UDI
- Model / Reference
- PA620 FDA UDI
- Description
- TRAY PA620 3/4 DIN INSTR CASE MR7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000337438 FDA UDI
- 510(k) Number
- K090112 FDA UDI
- FDA Product Code
- HBB FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4370 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument tray, reusable
Midas Rex by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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Cleared under the same submission
K090112 also covers:
- MIDAS REX MR7 — Medtronic Powered Surgical Solutions
- MIDAS REX MR7 — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — Medtronic Powered Surgical Solutions
- Midas Rex — 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 0d6a7ed0-b0b3-4f08-aa20-e829507488a6 35 fields · synced Jun 9, 2026