Identity
- Trade Name
- Rumex FDA UDI
- Generic Name
- LASEK alcohol well, reusable FDA UDI
- Device Name
- LASEK 9mm Trephine / 9.5mm Funnel, Depth of the incision 70 mkm, Length 130 mm, Round Titanium Handle FDA UDI
- Model / Reference
- 20-122 FDA UDI
- Description
- LASEK 9mm Trephine / 9.5mm Funnel, Depth of the incision 70 mkm, Length 130 mm, Round Titanium Handle FDA UDI
Identifiers
- Catalog Number
- 20-122 FDA UDI
- Primary DI / UDI-DI
- 00840159908013 FDA UDI
- FDA Product Code
- HRH FDA UDI
- GMDN Term
- LASEK alcohol well, 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: LASEK alcohol well, reusable
Rumex is a cutting-edge, manual ophthalmic surgical device designed for laser-assisted epithelial keratomileusis (LASEK) surgery. This device features a reusable reservoir of alcohol solution at the surface of the cornea, which softens the corneal epithelium before subsequent flap creation. The Trephine, Manual, Ophthalmic device holds a dedicated trephine blade at the eye's surface during flap creation, making it an ideal tool for ophthalmologists and surgeons.
Similar devices
Also classified as LASEK alcohol well, reusable.
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- Medetz Surgical Instruments — MEDETZ SURGICAL INSTRUMENTS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Rumex International Co.
Sources (1)
- FDA UDI 3b4fd0ed-36bd-4a70-b3ee-19c1816b7346 34 fields · synced Jul 11, 2026