1.7 mm Short PerCryo™ Cryoprobe
by Varian Medical Systems, Inc. United States EUDAMEDGUDID
Ref DP35-0942-205
Product code GEHEMDN Z120102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number089947500200133PP | Date17 Mar 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00810563020724 | Date18 Feb 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use
- Device Name
- Slimline Cryoprobes
- Model / Ref / Catalog
- DP35-0942-205, PCS-17RS
- Primary DI / UDI-DI
- 00810563020724
- Basic UDI-DI
- 089947500200133PP
- 510(k) Number
- FDA Product Code
- GEH
- EMDN Code
- Z120102 Cryosurgery equipment
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4350
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000007453
- Authorised representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Other devices from Varian Medical Systems, Inc
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED 4f175274-fdd3-4c8b-8029-2ec9f1450076
- FDA UDI 5ff64e3d-c1dc-4e75-a8ac-c63f89825e5e