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25G Two Dimensional Cutter – 16k CPM
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- 25G Two Dimensional Cutter – 16k CPM FDA UDI
- Generic Name
- Ophthalmic surgical instrument handle, pneumatic FDA UDI
- Model / Reference
- 8278.VIT25 FDA UDI
Identifiers
- Catalog Number
- 8278.VIT25 FDA UDI
- Primary DI / UDI-DI
- 08717872031965 FDA UDI
- 510(k) Number
- K190875 FDA UDI
- FDA Product Code
- HQE FDA UDI
- GMDN Term
- Ophthalmic surgical instrument handle, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 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 instrument handle, pneumatic
25G Two Dimensional Cutter – 16k CPM by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ophthalmic surgical instrument handle, pneumatic.
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- IRIS SCISSORS — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- SCISSORS — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- SCISSORS — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- SCISSORS — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- SCISSOR — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Raw Surgical Corporation — RAW SURGICAL CORPORATION · Class I
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 (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 50d44c0d-4178-4466-9435-e4a0b7ce9c17 34 fields · synced May 30, 2026