← Back to catalogue
Disposable Drapes, for Associate touch screen & remote control.
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Disposable Drapes, for Associate touch screen & remote control. FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Model / Reference
- 6279.SD FDA UDI
Identifiers
- Catalog Number
- 6279.SD FDA UDI
- Primary DI / UDI-DI
- 08717872013503 FDA UDI
- 510(k) Number
- K081877 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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: Ophthalmic surgical procedure kit, non-medicated, single-use
Disposable Drapes, for Associate touch screen & remote control. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI…
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
- 3 POLI-SAFE 60X45 C/ ADESIVO — Linea Sterile S.p.A. · Class I
- CustomEyes® — Beaver-Visitec International, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- LAPAROSCOPIC SLEEVE RESECTION PACK — Johnson & Johnson Medical GmbH · Class III
- KIT GINECOLOGIA LAPAROSCOPIA — Linea Sterile S.p.A. · Class I
- SET 273 Ambulant — BATIST Medical Productions s.r.o. · Class III
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K081877 also covers:
- Associate Cartridge with upgraded infusion line / drip chamber. Suitable for ant — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Blue infusion sleeve for 3004.FD & 3006.PF phaco needles — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- DORC VFI connector between DORC System & 1363.DD — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Associate Cartridge.(including exchangeable I/A tubing and fluid givi — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Eckardt One step Vitrectomy Kit.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Fluid Giving set for Associate REF: 6279.ASD1 Cartridge incl connecto — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Cannula Pack for Associate (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack for Associate (20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack for Associate (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack. (20 gauge/ 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack. (23 gauge/ 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack. (25 gauge/ 0.5 mm) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 31b613b0-a73d-4be4-bee2-d11f2e4ca5cf 34 fields · synced Jun 1, 2026