Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Flynn scleral Depressor, 5mm Loop. lens style, Overall Length 3 1/8" (8cm) FDA UDI
- Model / Reference
- ST13906501 FDA UDI
- Description
- Flynn scleral Depressor, 5mm Loop. lens style, Overall Length 3 1/8" (8cm) FDA UDI
Identifiers
- Catalog Number
- ST13906501 FDA UDI
- Primary DI / UDI-DI
- 00842180191396 FDA UDI
- FDA Product Code
- HNC 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 002b72a6-9e4a-42cf-baac-4d87e08562d0 35 fields · synced May 31, 2026