D.A.L.K. Spatula Dissection Set
FDA UDIEUDAMEDClass I (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- D.A.L.K. Spatula Dissection Set EUDAMEDFDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- D.A.L.K. Spatula Dissection Set EUDAMED
- Model / Reference
- 2110 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2110 FDA UDI
- Primary DI / UDI-DI
- 08717872008189 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717872008189 EUDAMED
- Direct Marketing DI
- 08717872008189 EUDAMED
- FDA Product Code
- HND FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Ophthalmic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic surgical probe, reusable
D.A.L.K. Spatula Dissection Set by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 31e8c7c9-efbc-450c-82f9-14b7e278f13d 33 fields · synced Oct 9, 2026
- EUDAMED a97e9aa7-bac5-468e-bcee-20ff489d7911 61 fields · synced Oct 9, 2026