Identity
- Trade Name
- E.DL SPXL LENS FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- E.DL SPXL LENS Box 10 use 196 741 FDA UDI
- Model / Reference
- 196 745 FDA UDI
- Description
- E.DL SPXL LENS Box 10 use 196 741 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841668111857 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Ophthalmic diagnostic condensing lens FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1385 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic diagnostic condensing lens
E.dl Spxl Lens by Katena Products, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI ee5e5cd6-7fdc-4af6-88fc-c04a3cddc9c2 35 fields · synced Jun 12, 2026