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Cryo Probe: Extended Retinal, 2.5mm
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Cryo Probe: Extended Retinal, 2.5mm FDA UDI
- Generic Name
- Ophthalmic cryosurgical system, electronic FDA UDI
- Model / Reference
- 1540.D FDA UDI
Identifiers
- Catalog Number
- 1540.D FDA UDI
- Primary DI / UDI-DI
- 08717872021416 FDA UDI
- 510(k) Number
- K160591 FDA UDI
- FDA Product Code
- HRN FDA UDI
- GMDN Term
- Ophthalmic cryosurgical system, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4170 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 cryosurgical system, electronic
Cryo Probe: Extended Retinal, 2.5mm by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
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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 a3c9012a-412f-4ecc-9abd-03c51b73a752 34 fields · synced Jun 1, 2026