Identity
- Trade Name
- APX 200 FDA UDI
- Generic Name
- Intraocular retractor, single-use FDA UDI
- Device Name
- The APX200 is a single patient, single use device, intended to provide expansion of the pupillary aperture. FDA UDI
- Model / Reference
- 200 FDA UDI
- Description
- The APX200 is a single patient, single use device, intended to provide expansion of the pupillary aperture. FDA UDI
Identifiers
- Catalog Number
- 200-300 FDA UDI
- Primary DI / UDI-DI
- 17290017069002 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Intraocular retractor, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Intraocular retractor, single-use
Apx 200 by Apx Ophthalmology Ltd — 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
- Apx Ophthalmology Ltd
Sources (1)
- FDA UDI 41aa3f3a-f354-47f0-a61f-883f99e8f272 35 fields · synced Jun 8, 2026