Manufactured in the U.S.A by IDM Tech, LLC for CryoPen, Inc.
Distributed by CryoPen, Inc
CryoPen
®
is a Registered Trademark of CryoPen, Inc. All Contents Copyright © All Rights Reserved
- 2 -
Originated Date: 02.25.2010
Revision Date: 5.1.2012
OM-CT2-01-R6
(Minimally invasive cryosurgical unit and accessories for physician use only)
Caution: “Federal law restricts this device to sale by or on the order of a Physician”.
Model number: CT-2000
Manufactured in the U.S.A. by IDM Tech, LLC for CryoPen, Inc.
Distributed by: CryoPen, Inc.
Corporate Office: 800 N. Shoreline Blvd. • Suite 900S • Corpus Christi TX 78401
p: 1.888.246.3928 efax: 1.281.754.4359 www.cryopen.com
CryoPen
®
Cooling System Assembly (1ea.)
Non-Sterile re-usable CryoPen
®
tip (1ea.) 3mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 5mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 7mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 10mm
Temperature Indicator (1ea.)
Reservoir Solution 500ml (1ea.)
Reservoir Tube- Plastic (23ml)
Reservoir Tube Cap (1ea.)
Cleaning Swabs –Single end 14”(6)
Transfer Pipette- ½ dozen
CryoPen® Operators Packet
Indications For Use:
Intended use: Cryosurgical unit used for ablative type surgical technique
Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant
tissue.
Contraindications:
The CryoPen
®
is contraindicated in patients with recurrent basal cell cancers; lesions on the lower extremities (i.e. feet,
ankles, lower legs) when circulation is in question, especially in patients with diabetes; lesions in the nasolabial fold or
preauricular area (basal cells often are more extensive in this area); lesions in the immediate periorbital area; port-wine
stains, lesions in areas in which hair loss or pigmentary changes are critical to the patient. Cryosurgery is not recommended
for Melanomas.
WARNING: Do NOT use the CryoPen
®
when the above listed conditions are present. The use of cryosurgical
procedures in the treatment of the above listed conditions may cause serious injury to the patient.
(128 pages)
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