Identity
- Trade Name
- QUATERA 700 FDA UDI
- Generic Name
- Phacoemulsification/vitrectomy system FDA UDI
- Device Name
- QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. The device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation and anterior vitrectomy. FDA UDI
- Model / Reference
- REF 6407 FDA UDI
- Description
- QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. The device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation and anterior vitrectomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539064073 FDA UDI
- FDA Product Code
- HQC FDA UDIHQE FDA UDI
- GMDN Term
- Phacoemulsification/vitrectomy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 FDA UDI886.4150 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/vitrectomy system
Quatera 700 by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification/vitrectomy system.
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- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA NEXUS™, Phaco emulsification system — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI e6c46906-c477-4b99-bd92-cb4f238641b7 33 fields · synced Jun 8, 2026