Identity
- Trade Name
- ELMED INCORPORATED FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- SINSKEY MICRO LENS HOOK 90DEG 4-5/8IN FDA UDI
- Model / Reference
- ST4338802 FDA UDI
- Description
- SINSKEY MICRO LENS HOOK 90DEG 4-5/8IN FDA UDI
Identifiers
- Catalog Number
- ST4338802 FDA UDI
- Primary DI / UDI-DI
- 00198506063480 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 Incorporated 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
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- 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 37325fee-1b2f-45d3-a9d5-3be70c231bac 35 fields · synced Jun 8, 2026