Identity
- Trade Name
- Primary Lens Set, 28D, 90D, 3 Mirror FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Model / Reference
- K31-3002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841668144268 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic diagnostic condensing lensLaser lens, ophthalmic, surgical
Primary Lens Set, 28D, 90D, 3 Mirror by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser lens, ophthalmic, surgical.
- Mag Plus Iridectomy (VMPIRID) — VOLK OPTICAL INC. · Class II
- QuadrAspheric NF (VQFLNF) — VOLK OPTICAL INC. · Class II
- Equator Plus ANF+ (VEPANF+) — VOLK OPTICAL INC. · Class II
- Iridectomy (VLUIRID) — VOLK OPTICAL INC. · Class II
- Iridectomy (VEIRID) — VOLK OPTICAL INC. · Class II
- Equator Plus NF (VEPNF) — VOLK OPTICAL INC. · Class II
- Disposable Capsulotomy (VCAPSD) — VOLK OPTICAL INC. · Class II
- Disposable Iridotomy (VIRIDD) — VOLK OPTICAL INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI b8ac3e58-ffb2-4dba-8b1c-3fe1ba958796 32 fields · synced Jun 12, 2026