Identity
- Trade Name
- Ellis Magnetic Foreign Body Remover FDA UDI
- Generic Name
- Eye spud FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 16108 FDA UDI
- Primary DI / UDI-DI
- B091161080 FDA UDI
- FDA Product Code
- HNA FDA UDI
- GMDN Term
- Eye spud 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Eye spud
Ellis Magnetic Foreign Body Remover by Gulden Ophthalmics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye spud.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Spud — Katena Products, Inc. · Class I
- Spud — Katena Products, Inc. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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
- Gulden Ophthalmics
Sources (1)
- FDA UDI ac3ec93a-13c5-4f52-850e-7078b58dd447 33 fields · synced Jun 8, 2026