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Prostate Procedure Probe Pack
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DP35-0965-102Ref DP35-0595-108
Identity
- Trade Name
- Prostate Procedure Probe Pack EUDAMEDFDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Prostate Procedure Probe Pack EUDAMEDProstate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea) FDA UDI
- Model / Reference
- DP35-0965-102 EUDAMEDDP35-0595-108 EUDAMEDFDA UDI
- Description
- Prostate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea) FDA UDI
Identifiers
- Catalog Number
- CRYO-207-V FDA UDI
- Primary DI / UDI-DI
- 00810563020922 EUDAMED00810563020939 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200149Q6 EUDAMED
- 510(k) Number
- K153489 FDA UDI
- FDA Product Code
- GEH FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Prostate Procedure Probe Pack by Varian Medical Systems, Inc — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200149Q6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000007453
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED 4e1bfbfd-d966-41f0-8011-11bdfceeb315 61 fields · synced Aug 1, 2026
- EUDAMED 605eb8bd-3b3c-4c1d-a031-fecf7f37edc6 61 fields · synced May 17, 2026
- FDA UDI f6919728-d123-450f-b610-7d11b95a457c 35 fields · synced May 30, 2026