Identity
- Trade Name
- Console, M2000, Enhanced FDA UDI
- Generic Name
- Phacoemulsification system FDA UDI
- Model / Reference
- 23-9023 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039020018 FDA UDI
- 510(k) Number
- K940084 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
Yes
FDA UDI
Category: Phacoemulsification system
Console, M2000, Enhanced by Medical Technical Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K940084 also covers:
- Console, M2000, Premium — MEDICAL TECHNICAL PRODUCTS, INC
- Console, M2000, Value — MEDICAL TECHNICAL PRODUCTS, INC
- Footpedal, M2000, Herga — MEDICAL TECHNICAL PRODUCTS, INC
- Footpedal, M2000, MTP — MEDICAL TECHNICAL PRODUCTS, INC
- Operators Manual, M2000, Premium — MEDICAL TECHNICAL PRODUCTS, INC
- Operators Manual, M2000, Premium, Chinese — MEDICAL TECHNICAL PRODUCTS, INC
- Operators Manual, M2000, Value — MEDICAL TECHNICAL PRODUCTS, INC
- Operators Manual, M2000, Value, Chinese — MEDICAL TECHNICAL PRODUCTS, 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
- Medical Technical Products, Inc
Sources (1)
- FDA UDI 505b2ead-46a5-40f4-90b0-38d73bf18805 34 fields · synced Jun 6, 2026