Identity
- Trade Name
- Medetz Surgical Instruments FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- Mackool/Cylindrical Spatula DBL-Ended with Short Handle, Mackool Phaco Chopper, Micro .38mm Ball Shaped Blunt tip with Interior Cutting Edge, Angled 10mm from bend to tip, / Cylindrical Spatula, .4 Blade Angled/Semi-Vaulted 11mm from bend to tip, Round Knurled Handle, 100mm Overall Length, FDA UDI
- Model / Reference
- 14-0617-s FDA UDI
- Description
- Mackool/Cylindrical Spatula DBL-Ended with Short Handle, Mackool Phaco Chopper, Micro .38mm Ball Shaped Blunt tip with Interior Cutting Edge, Angled 10mm from bend to tip, / Cylindrical Spatula, .4 Blade Angled/Semi-Vaulted 11mm from bend to tip, Round Knurled Handle, 100mm Overall Length, FDA UDI
Identifiers
- Primary DI / UDI-DI
- G223140617S0 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Ophthalmic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic surgical probe, reusable
Medetz Surgical Instruments by Medetz Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medetz Surgical Instruments
Sources (1)
- FDA UDI e5fd7591-d859-42d2-9469-13c6c0b2c71c 34 fields · synced May 30, 2026