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Illuminated Curved Laser probe, 25 gauge / 0, 5mm with DORC® connector
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Illuminated Curved Laser probe, 25 gauge / 0,5mm with DORC® connector FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Model / Reference
- 7625.DORC FDA UDI
Identifiers
- Catalog Number
- 7625.DORC FDA UDI
- Primary DI / UDI-DI
- 08717872027463 FDA UDI
- 510(k) Number
- K132614 FDA UDI
- FDA Product Code
- HQB FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4690 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 laser system beam guide
Illuminated Curved Laser probe, 25 gauge / 0, 5mm with DORC® connector by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI…
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Also classified as Ophthalmic laser system beam guide.
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Cleared under the same submission
K132614 also covers:
- Illuminated Curved Laser probe, 25 gauge / 0, 5mm with Alcon connector — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 25GA Curved Alcon Illuminating Laser Probe - Iridex - Short — Peregrine Surgical, LLC.
- 25GA Curved Illuminating Laser Probe — Peregrine Surgical, LLC.
- 27GA Curved Illuminating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 27GA Curved Illuminating Laser Probe - DORC — Peregrine Surgical, LLC.
- 27GA Curved Illuminating Laser Probe - Iridex — Peregrine Surgical, LLC.
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 90fac89a-a658-44c6-af5b-badabf191e5c 34 fields · synced Jun 6, 2026