Identity
- Trade Name
- 8mm Cryoprobe EUDAMEDFDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Straight Cryoprobe EUDAMEDStraight 8mm cryoprobe for use with Cryocare Systems FDA UDI
- Model / Reference
- DP35-0215-101 EUDAMEDFDA UDI
- Description
- Straight 8mm cryoprobe for use with Cryocare Systems FDA UDI
Identifiers
- Catalog Number
- CRYO-48-F FDA UDI
- Primary DI / UDI-DI
- 00810563020953 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200134PR EUDAMED
- 510(k) Number
- K011074 FDA UDI
- FDA Product Code
- OCL 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
- 878.4400 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
8mm Cryoprobe 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 | 089947500200134PR | 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 (2)
- EUDAMED 6c5d6567-12d9-4a95-bec9-e20fc4af7dd0 61 fields · synced Jun 19, 2026
- FDA UDI 261dcc40-bb12-4245-a0c3-bf048c2584ba 35 fields · synced May 30, 2026