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2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref PC-2.1EL

by Varian Medical Systems, Inc.

Identity

Trade Name
2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal EUDAMED
ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal FDA UDI
Generic Name
Cryosurgical set FDA UDI
Device Name
ISOLIS Cryoprobe EUDAMED
Model / Reference
PC-2.1EL EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00810563022056 EUDAMEDFDA UDI
Basic UDI-DI
089947500200144PU EUDAMED
510(k) Number
K230271 FDA UDI
FDA Product Code
GEH FDA UDI
EMDN Code
Z120102 CRYOSURGERY EQUIPMENT EUDAMED
GMDN Term
Cryosurgical set FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class 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
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal by Varian Medical Systems, Inc — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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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 f8731ccd-9b41-4eab-8752-24c67edfadd4 61 fields · synced Jul 11, 2026
  • FDA UDI b2b68d6e-a6c7-4d6d-9cb7-80f43a7f4237 33 fields · synced May 30, 2026
  • FDA 510(k) K230271 1 fields · synced May 18, 2026