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2.2 mm Straight phaco needle. (disposable)
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- 2.2 mm Straight phaco needle. (disposable) FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDI
- Model / Reference
- 8400.22S01 FDA UDI
Identifiers
- Catalog Number
- 8400.22S01 FDA UDI
- Primary DI / UDI-DI
- 08717872018768 FDA UDI
- 510(k) Number
- K190875 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece tip, 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: Phacoemulsification system handpiece tip, single-use
2.2 mm Straight phaco needle. (disposable) 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 Phacoemulsification system handpiece tip, single-use.
- LAMINAR — Johnson & Johnson Surgical Vision, Inc. · Class II
- CANNULA — MED LOGICS INC · Class IIa
- UNITY — Alcon Laboratories, Inc. · Class IIb
- Sterile Light Fibers — Vitreq B.V. · Class IIa
- UNITY — Alcon Laboratories, Inc. · Class IIb
- Constellation — Alcon Laboratories, Inc. · Class IIb
- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, Inc. · Class II
- UNITY — Alcon Laboratories, Inc. · Class IIa
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 df7c09ce-f8c1-47a0-b11c-702aa6cee35d 34 fields · synced May 30, 2026