Full Handle Backflush 20G Brush tip Extensible Active/Passive
- Primary DI
- 08052276015778
- Brand
- Full Handle Backflush 20G Brush tip Extensible Active/Passive
- Company
- AKTIVE SRL
- Model
- AK-0453/AP-EX
- Catalog number
- AK-0453/AP-EX
- Device description
- Full Handle Backflush 20G Brush tip Extensible Active/Passive
- Published
- 2023-06-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| KYG | Device, Irrigation, Ocular Surgery |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08052276026439 | Primary | GS1 | 0 | |
| 08052276015778 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08052276026439 | 08052276026439 | 8052276026439 |
| 08052276015778 | 08052276015778 | 8052276015778 |
GMDN Terms
| Term | Definition |
|---|
| Vitrectomy fluid/gas handling handpiece/cannula | A sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 5 Degrees Celsius | 40 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 433533053
- Device count
- 6
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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