Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Vital™ Knapp iris scissors Sharp/sharp. Blades 2.8cm from mid-screw. Stelliter cutting edges. Overall length 4-1/2in (11.4cm). Straight. FDA UDI
- Model / Reference
- EL-OP5526 FDA UDI
- Description
- Vital™ Knapp iris scissors Sharp/sharp. Blades 2.8cm from mid-screw. Stelliter cutting edges. Overall length 4-1/2in (11.4cm). Straight. FDA UDI
Identifiers
- Catalog Number
- EL-OP5526 FDA UDI
- Primary DI / UDI-DI
- 00842180173378 FDA UDI
- FDA Product Code
- HNF FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, reusable.
- PHACOFIT — Johnson & Johnson Surgical Vision, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- SOLO — Johnson & Johnson Surgical Vision, Inc. · Class I
- US Tip Pack, 20GA, 30DEG, SH — MEDICAL TECHNICAL PRODUCTS, INC · Class II
- SOLO — Johnson & Johnson Surgical Vision, Inc. · Class I
- US Tip Pack, 19GA, 30DEG, SH — MEDICAL TECHNICAL PRODUCTS, INC · Class II
- PHACOFIT — Johnson & Johnson Surgical Vision, Inc. · Class I
- PHACOFIT — Johnson & Johnson Surgical Vision, 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
- Elmed Incorporated
Sources (1)
- FDA UDI 46dadf8d-4751-44d8-9397-8a8a1705e4d4 35 fields · synced May 30, 2026