FDA UDI
In Commercial Distribution
🇺🇸 United States
Full Handle Backflush 25G Soft tip Active/Passive (1,5 mm)
DI: 08052276026545
·
Model: AK-0458/APXL
·
AKTIVE SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Full Handle Backflush 25G Soft tip Active/Passive (1,5 mm)
- Primary DI
- 08052276026545
- Version / Model
- AK-0458/APXL
- Catalog Number
- AK-0458/APXL
- Company Name
- AKTIVE SRL
- Labeler DUNS
- 433533053
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- 443bfe9f-589e-4310-a712-ffc68c46592a
Device Description
Full Handle Backflush 25G Soft tip Active/Passive (1,5 mm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 886.4360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47130 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08056477559253 | GS1 | ||||
| Primary | 08052276026545 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | GAUGE |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius