Identity
- Trade Name
- US Handpiece, Standard, Meda FDA UDI
- Generic Name
- Phacoemulsification system handpiece FDA UDI
- Model / Reference
- 01-899246 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039020094 FDA UDI
- 510(k) Number
- K940088 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Phacoemulsification system handpiece
US Handpiece, Standard, Meda by Medical Technical Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece.
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- 2.2 mm Reusable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
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- Irrigation sleeve for 1.8 mm phaco needle. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
Cleared under the same submission
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 b0b1eea7-1102-4197-8df6-4a496c908763 34 fields · synced May 31, 2026