Malosa Medical
- Primary DI
- 05055186206444
- Brand
- Malosa Medical
- Company
- Beaver-Visitec International, Inc.
- Model
- MMSU1197S
- Catalog number
- MMSU1197S
- Device description
- Epithelium Well 8.5mm
- Published
- 2022-02-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 35055186206445 | Primary | GS1 | 0 | |
| 05055186206444 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 35055186206445 | 35055186206445 | |
| 05055186206444 | 05055186206444 | 5055186206444 |
GMDN Terms
| Term | Definition |
|---|
| LASEK alcohol well, single-use | 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 single-use device. |
Contacts
| Phone | Email |
|---|
| 18669068080 | customersupport@beaver-visitec.com |
Regulatory Flags
- DUNS number
- 001406024
- Device count
- 20
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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