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Endo-diathermy handle, straight pointed tip.(25 gauge / 0.5 mm)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1120.05
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Endo-diathermy handle, straight pointed tip (25 gauge / 0.5 mm) EUDAMEDEndo-diathermy handle, straight pointed tip.(25 gauge / 0.5 mm) FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Endo-diathermy handle, straight pointed tip (25 gauge / 0.5 mm) EUDAMED
- Model / Reference
- 1120.05 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1120.05 FDA UDI
- Primary DI / UDI-DI
- 08717872000398 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717872000398 EUDAMED
- Direct Marketing DI
- 08717872000398 EUDAMED
- 510(k) Number
- K190875 FDA UDI
- FDA Product Code
- HQR FDA UDI
- EMDN Code
- Z1212020682 OPHTHALMIC ELECTROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4100 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Endo-diathermy handle, straight pointed tip.(25 gauge / 0.5 mm) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — MDD, FDA UDI…
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Cleared under the same submission
K190875 also covers:
- 2.2 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step angled flared phaco needle. (disposable) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.5 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Disposable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Reusable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 7bcdce6a-b16c-4487-ba8c-3ce3fbed23a7 34 fields · synced Oct 9, 2026
- EUDAMED 5ede3d03-4afd-481d-afee-a89d9ef7830a 61 fields · synced Oct 8, 2026