Bausch + Lomb
- Primary DI
- 00757770520107
- Brand
- Bausch + Lomb
- Company
- Bausch & Lomb Incorporated
- Model
- E9108
- Catalog number
- E9108
- Device description
- MACRAE LASEK OVAL WELL
- Published
- 2024-11-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HMR | Marker, Ocular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HMR | Marker, Ocular | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00757770520107 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00757770520107 | 00757770520107 | 757770520107 | 0757770520107 |
GMDN Terms
| Term | Definition |
|---|
| LASEK alcohol well, reusable | A hand-held, manual, ophthalmic surgical device designed to hold a small reservoir of alcohol solution at the surface of the cornea to soften the corneal epithelium for subsequent epithelial flap creation during laser-assisted epithelial keratomileusis (LASEK) surgery. It may additionally be designed to hold/assist placement of the dedicated trephine (cylindrical cutting blade) at the surface of the eye during flap creation. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 196603781
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 00757770492312 | Bausch + Lomb | Bausch & Lomb Incorporated | HMR | 2025-08-04 |
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