Identity
- Trade Name
- HD Disposable, LenZ FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- 1 HD Disposable LenZ FDA UDI
- Model / Reference
- 54026 FDA UDI
- Description
- 1 HD Disposable LenZ FDA UDI
Identifiers
- Catalog Number
- 54026 FDA UDI
- Primary DI / UDI-DI
- 00852475007165 FDA UDI
- FDA Product Code
- HJL FDA UDI
- GMDN Term
- Ophthalmic diagnostic condensing lens FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1380 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
Dimensions & Sizes
- Size
- Outer Diameter — 18 Millimeter FDA UDI
Category: Ophthalmic diagnostic condensing lens
HD Disposable, LenZ by Oculus Surgical Inc — 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
- Oculus Surgical Inc
Sources (1)
- FDA UDI 263cd793-10d7-4b59-b055-5af06133bdce 37 fields · synced Jun 1, 2026