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Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD. FDA UDI
- Generic Name
- Vitrectomy contact lens, single-use FDA UDI
- Model / Reference
- 1284.DIS FDA UDI
Identifiers
- Catalog Number
- 1284.DIS FDA UDI
- Primary DI / UDI-DI
- 08717872004280 FDA UDI
- 510(k) Number
- K033950 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Vitrectomy contact lens, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1385 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vitrectomy contact lens, single-use
Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA…
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Cleared under the same submission
K033950 also covers:
- Disposable Vitrectomy Lens: 30° Prism — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Vitrectomy Lens: Biconcave — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Vitrectomy Lens: Flat — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Vitrectomy Lens: Magnifying — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Vitrectomy Lens: Wide View — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Suturable vitrectomy lens ring 1284.DW till 1284.IW — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WideView Vitrectomy Lens: 20° Prism — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WideView Vitrectomy Lens: 30° Prism — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WideView Vitrectomy Lens: Biconcave — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WideView Vitrectomy Lens: Flat — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WideView Vitrectomy Lens: Wide Field — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI c645e3dd-3def-497f-bea3-f77db9f31e97 34 fields · synced May 30, 2026