Identity
- Trade Name
- ZEISS Optical Insert- Reader FDA UDI
- Generic Name
- Prescription spectacle lens, custom-made FDA UDI
- Device Name
- ZEISS Optical Insert- Reader FDA UDI
- Model / Reference
- 39000033082 FDA UDI
- Description
- ZEISS Optical Insert- Reader FDA UDI
Identifiers
- Catalog Number
- 39000033082 FDA UDI
- Primary DI / UDI-DI
- 04064495039408 FDA UDI
- FDA Product Code
- HOI FDA UDI
- GMDN Term
- Prescription spectacle lens, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5840 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Prescription spectacle lens, custom-made
ZEISS Optical Insert- Reader by Carl Zeiss Vision International GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prescription spectacle lens, custom-made.
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
- Carl Zeiss Vision International GmbH
Sources (1)
- FDA UDI 18c7967d-c052-4a0f-9e53-d14857983230 35 fields · synced Jun 1, 2026