DMEK Surgical Disposable Set
- Primary DI
- 18717872018161
- Brand
- DMEK Surgical Disposable Set
- Company
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Model
- 50.2200
- Catalog number
- 50.2200
- Published
- 2021-01-29
- 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 |
|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08717872018164 | Primary | GS1 | 0 | |
| 18717872018161 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08717872018164 | 08717872018164 | 8717872018164 |
| 18717872018161 | 18717872018161 | |
GMDN Terms
| Term | Definition |
|---|
| Donor cornea delivery set | A collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device. |
Regulatory Flags
- DUNS number
- 407522184
- Device count
- 3
- DM exempt
- false
- Premarket exempt
- true
- 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 |
|---|
| 08717872001401 | Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max. | 1267.NMD05 | 1267.NMD05 | 2016-09-30 |
| 08717872001425 | Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max. | 1267.NMD25 | 1267.NMD25 | 2016-09-30 |
| 08717872003085 | Infusion cannula forceps | 1276 | 1276 | 2020-11-16 |
| 08717872003115 | Scleral plug forceps | 1277 | 1277 | 2020-11-16 |
| 08717872003375 | Charles Flute instrument. | 1281 | 1281 | 2020-11-16 |
| 08717872004280 | Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD. | 1284.DIS | 1284.DIS | 2016-09-23 |
| 08717872008578 | Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max. | 2267.NMD06 | 2267.NMD06 | 2016-09-30 |
| 08717872016771 | Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max | 2267.NMD04 | 2267.NMD04 | 2016-09-23 |
| 08717872017297 | Disposable Pneumatic Vitrectome, 25 Gauge/0.5 mm working with 37 PSI, max2500 c | 2267.NMD05 | 2267.NMD05 | 2016-09-23 |
| 08717872021416 | Cryo Probe: Extended Retinal, 2.5mm | 1540.D | 1540.D | 2017-07-12 |
| 08717872037103 | 25G Extendible subretinal injection cannula (41G) | 1270.EXT25 | 1270.EXT25 | 2025-09-26 |
| 08717872037110 | 27G Extendible subretinal injection cannula (41G) | 1270.EXT27 | 1270.EXT27 | 2025-09-26 |
| 18717872035496 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | 3269.E06-00 | | 2025-04-01 |
| 18717872035540 | TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) | 3269.EB05-00 | | 2025-04-01 |
| 18717872036547 | 27G Two Dimensional Cutter – 20k CPM | 9268.VIT27-00 | | 2025-04-01 |
| 08717872034720 | EVA Custom TDC Vitrectomy Pack VGPC Input 27G | 8527.402-00 | | 2025-03-31 |
| 18717872035397 | Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4 | 3269.D04-00 | | 2025-03-31 |
| 18717872035403 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | 3269.D-00 | | 2025-03-31 |
| 18717872035410 | TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga | 3269.B04-00 | 3269.B04-00 | 2025-03-31 |
| 18717872035427 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | 3269.SBS06-00 | | 2025-03-31 |
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