Identity
- Trade Name
- OPT™ Shields FDA UDI
- Generic Name
- Radiation/mechanical corneal shield, single-use FDA UDI
- Model / Reference
- NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290117772420 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Radiation/mechanical corneal shield, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 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
Yes
FDA UDI
Category: Radiation/mechanical corneal shield, single-use
OPT™ Shields by Lumenis Be, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation/mechanical corneal shield, single-use.
- OptiSet™ — Lumenis Be, 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
- Lumenis Be, Inc.
Sources (1)
- FDA UDI 30c6624b-fa96-43bc-82bd-34e8e77b5b2e 32 fields · synced May 30, 2026