Identity
- Trade Name
- Bausch + Lomb FDA UDI
- Generic Name
- LASEK alcohol well, reusable FDA UDI
- Device Name
- MACRAE LASEK WELL 6.5 MM FDA UDI
- Model / Reference
- E9105 FDA UDI
- Description
- MACRAE LASEK WELL 6.5 MM FDA UDI
Identifiers
- Catalog Number
- E9105 FDA UDI
- Primary DI / UDI-DI
- 00757770500444 FDA UDI
- FDA Product Code
- HNX 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
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
No
FDA UDI
Category: LASEK alcohol well, reusable
Bausch + Lomb by Bausch & Lomb Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as LASEK alcohol well, reusable.
- Rumex — Rumex International Co. · Class I
- Rumex — Rumex International Co. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Rumex — Rumex International Co. · Class I
- Rumex — Rumex International Co. · Class I
- Medetz Surgical Instruments — MEDETZ SURGICAL INSTRUMENTS · Class I
- MSI Precision Specialty Instruments — Med Saver, 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
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI f80f393c-8829-48de-8f10-bb1aa47d6018 34 fields · synced Jun 8, 2026