Identity
- Trade Name
- Diamatrix FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Lehner Eye Speculum, .035" Stainless wire, This design is intended to lay over the bridge of the nose, 14mm Open square blades, 18mm Blade spread, 41mm total length, Stainless FDA UDI
- Model / Reference
- W80N-14 FDA UDI
- Description
- Lehner Eye Speculum, .035" Stainless wire, This design is intended to lay over the bridge of the nose, 14mm Open square blades, 18mm Blade spread, 41mm total length, Stainless FDA UDI
Identifiers
- Catalog Number
- W80N-14 FDA UDI
- Primary DI / UDI-DI
- 00813059017239 FDA UDI
- FDA Product Code
- HNC FDA UDI
- GMDN Term
- Eyelid speculum, 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: Eyelid speculum, reusable
Diamatrix by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyelid speculum, reusable.
- Sklar® — Sklar Corporation · Class I
- Ophthalmic Speculum — AURORA SURGICAL, LLC · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- COOK EYE SPECULUM — SONTEC INSTRUMENTS, 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
- Diamatrix
Sources (1)
- FDA UDI db560ae2-2964-4df5-bc71-2fd07f2d523a 35 fields · synced May 30, 2026