Spaide TotalView Endoillumination Probe, including illuminated scleral depressor
- Primary DI
- 18717872035564
- Brand
- Spaide TotalView Endoillumination Probe, including illuminated scleral depressor
- Company
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Model
- 3269.SB06-00
- Published
- 2025-03-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| MPA | Endoilluminator |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K062895 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08717872035567 | Primary | GS1 | 0 | |
| 18717872035564 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08717872035567 | 08717872035567 | 8717872035567 |
| 18717872035564 | 18717872035564 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ophthalmic fibreoptic light instrument, single-use | A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. 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 |
|---|---|---|---|---|
| 00893872001653 | iTrack 250E | Nova Eye, Inc. | MPA | 2026-05-05 |
| 00817325025010 | iChopper | MEDIMAX TECH INC. | MPA | 2026-04-30 |
| 00893872001684 | iTrack Advance | Nova Eye, Inc. | MPA | 2026-04-15 |
| 00893872001660 | iLumin | Nova Eye, Inc. | MPA | 2026-01-09 |
| 00840096215304 | XLEND23MULTIFLEX | KATALYST SURGICAL LLC | MPA | 2025-06-24 |
| 00840096215311 | XLEND25MULTIFLEX | KATALYST SURGICAL LLC | MPA | 2025-06-24 |
| 00810123483648 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-19 |
| 00810123483617 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 00810123483624 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 00810123483631 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 08717872035499 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 08717872035543 | TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 18717872035496 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 18717872035540 | TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 08717872035406 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035420 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035444 | Shielded TotalView Endoillumination Probe, including illuminated scleral depress | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035451 | TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035468 | TotalView Endoillumination Probe, including illuminated scleral depressor.(25 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035475 | Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035482 | Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035505 | TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035512 | Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035529 | Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035550 | Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035567 | Spaide TotalView Endoillumination Probe, including illuminated scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035581 | TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035598 | Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge / | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 18717872035403 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 18717872035427 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |