EVA Nexus™ Irrigation Tubing
- Primary DI
- 18717872032983
- Brand
- EVA Nexus™ Irrigation Tubing
- Company
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Model
- 9110.IRR01
- Published
- 2022-07-01
- 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 |
|---|---|
| HQC | Unit, Phacofragmentation |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K213467 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08717872032986 | Primary | GS1 | 0 | |
| 18717872032983 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08717872032986 | 08717872032986 | 8717872032986 |
| 18717872032983 | 18717872032983 |
GMDN Terms#
| Term | Definition |
|---|---|
| Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 407522184
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- false
- 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08717872031804 | EVA Custom TDC Vitrectomy Pack VGPC Input 23G | 8523.422 | 2021-06-11 | |
| 08717872003221 | Universal silicone infusion line for 20 gauge/0.9 mm cannula system. | 1279.IA20 | 1279.IA20 | 2021-02-01 |
| 08717872003245 | Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP2 | 1279.P | 1279.P | 2021-02-01 |
| 08717872003993 | Disposable Backflush instrument, with extended silicone tip and active aspiratio | 1281.TDM | 1281.TDM | 2021-02-02 |
| 08717872004013 | Replacement backflush reservoir with active aspiration. | 1281.XD | 1281.XD | 2021-02-02 |
| 08717872004075 | MVR Blade 23-G, angled | 1282.D06 | 1282.D06 | 2021-02-09 |
| 08717872004099 | One step stiletto insertor.(23 gauge / 0.6 mm) | 1282.F06 | 1282.F06 | 2021-02-09 |
| 08717872007403 | Disposable keratoscope | 1420.D | 1420.D | 2023-09-14 |
| 08717872012339 | Crescent Knife, 2.25, 55°, bevel up | 51.1118 | 51.1118 | 2021-01-29 |
| 08717872012346 | Slit Knife, 2.2mm, angled 45°, bibevel | 51.3722 | 51.3722 | 2021-01-29 |
| 08717872012384 | MVR Blade 20G, straight | 51.5230 | 51.5230 | 2021-01-29 |
| 08717872015255 | Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo | 1279.IA20S | 1279.IA20S | 2021-02-01 |
| 08717872015712 | MVR Blade 20G, angled | 52.5220 | 52.5220 | 2021-01-29 |
| 08717872015736 | Trapezoid Knife 1.2 x 1.4mm, angled | 53.1214 | 53.1214 | 2021-01-29 |
| 08717872015743 | Slit Knife, 2.2mm, angled, bevel up | 53.3722 | 53.3722 | 2021-01-29 |
| 08717872015750 | Slit Knife, 2.75mm, angled, bevel up | 53.3727 | 53.3727 | 2021-01-29 |
| 08717872015798 | Clear Corneal Knife, 2.5mm, angled | 54.5725 | 54.5725 | 2021-01-29 |
| 08717872015934 | Stab Knife, 15° | 51.4891 | 51.4891 | 2021-01-29 |
| 08717872031811 | EVA Custom TDC Vitrectomy Pack VGPC Input 25G | 8525.409 | 8525.401 | 2021-06-11 |
| 08717872031828 | EVA Custom TDC Vitrectomy Pack VGPC Input 27G | 8527.406 | 8525.401 | 2021-06-11 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10757770060464 | Bausch + Lomb | Bausch & Lomb Incorporated | HQC | 2026-04-09 |
| 07630055210319 | Phaco Set Sophi - 20G/30° | This AG | HQC | 2026-02-11 |
| 07630055210326 | Phaco Set Sophi - 21G/30° | This AG | HQC | 2026-02-11 |
| 07630055210333 | Phaco Set Sophi - 23G/30° | This AG | HQC | 2026-02-11 |
| 07630055210807 | Phaco Set Sophi - 20G/Curved | This AG | HQC | 2026-02-11 |
| 07630055210814 | Phaco Set Sophi - 21G/Curved | This AG | HQC | 2026-02-11 |
| 07630055210821 | Phaco Set Sophi - 23G/Curved | This AG | HQC | 2026-02-11 |
| 07630055252883 | HighVac Phaco Set Sophi - 21G/30° 0.45 | This AG | HQC | 2026-02-11 |
| 07630055253293 | Dynamic Phaco Set Sophi - 20G/30° | This AG | HQC | 2026-02-11 |
| 07640179410762 | Cassette Peristaltic Sophi | This AG | HQC | 2026-02-11 |
| 07640179410786 | Cassette Peristaltic & Venturi Sophi | This AG | HQC | 2026-02-11 |
| 07640179410809 | Cassette Peristaltic Sophi ECO | This AG | HQC | 2026-02-11 |
| 08717872035390 | Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872035413 | TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872035437 | Shielded TotalView Endoillumination Probe, including illuminated scleral depress | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872035536 | 27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral dep | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872035604 | Shielded TotalView Endoillumination Probe, including illuminated scleral depress | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872036526 | EVA Cartridge with 0.5 L Collection Bag | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872036588 | Disposable EVA Air Fluid Dual Tubing | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872036595 | Disposable EVA Drapes | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 08717872036601 | Disposable EVA VGPC Input Set | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2025-03-31 |
| 07630003915709 | Oertli® | Oertli-Instrumente AG | HQC | 2024-10-15 |
| 08717872034713 | CUSTOM TDC VITREC.PACK VGP 25G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-09-27 |
| 08717872034652 | EVA Vitrectomy Pack VGPC Input 20G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034683 | EVA TDC Vitrectomy Pack VGPC Input 23G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034690 | EVA TDC Vitrectomy Pack VGPC Input 25G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034706 | EVA TDC Vitrectomy Pack VGPC Input 27G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034744 | EVA NEXUS™ Combined 23G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034768 | EVA NEXUS™ Combined 25G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |
| 08717872034782 | EVA NEXUS™ Combined 27G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC | 2024-02-20 |