Gemcision™ Keratome Lancet, 3.8mm Width/Box of 5
- Primary DI
- 00840096207019
- Brand
- Gemcision™ Keratome Lancet, 3.8mm Width/Box of 5
- Company
- KATALYST SURGICAL LLC
- Model
- 7900-K38b
- Device description
- Gemcision™ Keratome Lancet, 3.8mm Width/Box of 5
- Published
- 2020-06-01
- Public version status
- Update
- Distribution status
- Not 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 |
|---|
| HNN | Knife, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HNN | Knife, Ophthalmic | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840096207019 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840096207019 | 00840096207019 | 840096207019 | 0840096207019 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic knife, reusable | A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 007883297
- 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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