926823G Two Dimensional Cutter – 20k CPM
- Primary DI
- 08717872036519
- Brand
- 926823G Two Dimensional Cutter – 20k CPM
- Company
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Model
- 9268.VIT23-00
- Catalog number
- 9268.VIT23-00
- Published
- 2025-03-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K213467 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08717872036519 | Primary | GS1 | 0 | |
| 18717872036516 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08717872036519 | 08717872036519 | 8717872036519 |
| 18717872036516 | 18717872036516 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ophthalmic surgical instrument handle, pneumatic | A sterile, hand-held, pneumatically-powered device designed to hold and operate a compatible ophthalmic surgical instrument tip (e.g., scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a pneumatic feedline (tubing) that connects to a parent device with gas source; when gas is supplied to the handle, typically using a foot-switch, a mechanism is activated to operate the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 407522184
- Device count
- 6
- Lot or batch
- true
- Expiration date on label
- true
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 |
|---|---|---|---|---|
| 00812480011137 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480011151 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480011168 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480011175 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480011182 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480013049 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-27 |
| 00812480011083 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-26 |
| 00812480011090 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-26 |
| 00812480011144 | Bi-Blade® | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HQE | 2026-09-26 |
| 10757770060464 | Bausch + Lomb | Bausch & Lomb Incorporated | HQE | 2026-04-09 |
| 10757770060471 | Bausch + Lomb | Bausch & Lomb Incorporated | HQE | 2026-04-09 |
| 10757770060488 | Bausch + Lomb | Bausch & Lomb Incorporated | HQE | 2026-04-09 |
| 00380650003294 | UNITY | Alcon Laboratories, Inc. | HQE | 2025-04-08 |
| 08717872036540 | 27G Two Dimensional Cutter – 20k CPM | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-04-01 |
| 08717872036526 | EVA Cartridge with 0.5 L Collection Bag | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036588 | Disposable EVA Air Fluid Dual Tubing | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036489 | EVA NEXUS™ Irrigation and Aux. Aspiration Tubing | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036496 | EVA NEXUS™ Infusion Giving Set | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036502 | EVA Nexus™ Irrigation Tubing | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036618 | EVA Nexus™ Aux. Aspiration Tubing | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872036625 | EVA NEXUS™ cartridge with 0,5 L collection bag | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2025-03-31 |
| 08717872034713 | CUSTOM TDC VITREC.PACK VGP 25G | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-09-27 |
| 00380650001252 | UNITY | Alcon Laboratories, Inc. | HQE | 2024-07-02 |
| 08717872035109 | EVA NEXUS™ Posterior 23G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035116 | EVA NEXUS™ Posterior 25G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035123 | EVA NEXUS™ Posterior 27G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035307 | EVA NEXUS™ Posterior 23G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035314 | EVA NEXUS™ Posterior 25G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035321 | EVA NEXUS™ Posterior 27G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |
| 08717872035338 | EVA NEXUS™ Combined 23G TDC Pack | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 2024-02-21 |