Alcon
- Primary DI
- 10380657517067
- Brand
- Alcon
- Company
- Alcon Laboratories, Inc.
- Model
- 8065751706
- Device description
- 25 GA Sclerotomy/Infusion 3.2mm Set; Contains (25 GA) sew-on Infusion Cannula, Scleral Plugs, and EDGEPLUS® Blade
- Published
- 2016-09-24
- Public version status
- Update
- 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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10380657517067 | Package | GS1 | 12 | In Commercial Distribution |
| 00380657517060 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10380657517067 | 10380657517067 | | |
| 00380657517060 | 00380657517060 | 380657517060 | 0380657517060 |
GMDN Terms
| Term | Definition |
|---|
| Vitrectomy system handpiece | A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 008018525
- Device count
- 1
- 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
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 07630055210449 | Phaco Set Sophi - 20G/30° | This AG | HQC | 2026-02-11 |
| 07630055210456 | Phaco Set Sophi - 21G/30° | This AG | HQC | 2026-02-11 |
| 07630055210463 | Phaco Set Sophi - 23G/30° | This AG | HQC | 2026-02-11 |
| 07630055210869 | Phaco Set Sophi - 20G/Curved | This AG | HQC | 2026-02-11 |
| 07630055210876 | Phaco Set Sophi - 21G/Curved | This AG | HQC | 2026-02-11 |
| 07630055210883 | Phaco Set Sophi - 23G/Curved | This AG | HQC | 2026-02-11 |
| 07630055242884 | HighVac Phaco Set Sophi - 21G/30° 0.45 | This AG | HQC | 2026-02-11 |
| 07630055243294 | Dynamic Phaco Set Sophi - 20G/30° | This AG | HQC | 2026-02-11 |
| 07640179410236 | SOPHI A | This AG | HQC | 2026-02-11 |
| 07640179410755 | Cassette Peristaltic Sophi | This AG | HQC | 2026-02-11 |
| 07640179410779 | Cassette Peristaltic & Venturi Sophi | This AG | HQC | 2026-02-11 |
| 07640179410793 | Cassette Peristaltic Sophi ECO | This AG | HQC | 2026-02-11 |
| 07640179410007 | SOPHI | This AG | HQC | 2026-02-10 |
| 07640179410090 | SOPHI | This AG | HQC | 2026-02-10 |
| 07630003909104 | Oertli® | Oertli-Instrumente AG | HQC | 2025-12-19 |
| 07630003910339 | Oertli® | Oertli-Instrumente AG | HQC | 2025-12-19 |
| 00380650002976 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-11-18 |
| 07630003920178 | Oertli® | Oertli-Instrumente AG | HQC | 2025-09-19 |
| 00850005541080 | MICOR Auto I/A | Carl Zeiss Meditec, Cataract Technology, Inc. | HQC | 2025-08-19 |
| 00757770684571 | Bausch + Lomb | Bausch & Lomb Incorporated | HQC | 2025-07-18 |
| 10380650003208 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003215 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003222 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003239 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003352 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003369 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003376 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003383 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 10380650003437 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
| 00380650003447 | UNITY | Alcon Laboratories, Inc. | HQC | 2025-04-07 |
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