MSI Precision Specialty Instruments
- Primary DI
- 00194613111007
- Brand
- MSI Precision Specialty Instruments
- Company
- Med Saver, Inc.
- Model
- 5-4237-T
- Device description
- Corneal Marker, Titanium, Double Ended, 8.5mm/9mm, Crosshairs, Used to Provide a Template For Scoring Stripping Descemet's Membrane during DSEK
- Published
- 2025-08-01
- 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 |
|---|
| 00194613111007 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00194613111007 | 00194613111007 | 194613111007 | 0194613111007 |
GMDN Terms
| Term | Definition |
|---|
| Corneal marker, reusable | A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 556623486
- 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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