Merit Medical Embosphere Microspheres Prefilled Syringe IFU-US User Manual
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All Indications
1. Bendszus M, Klein R, Burger R, et al.: Efficacy of trisacryl gelatin microspheres
versus polyvinyl alcohol particles in the preoperative embolization of
meningiomas. AJNR, 21(2): 255-61, Feb 2000.
2. Deveikis JP: Endovascular therapy of intracranial arteriovenous
malformations: materials and techniques. Neuroimaging Clin of N Am,
8(2):401-424, 1998.
3. Frizzel RT, Fisher WS: Cure, morbidity, and mortality associated with
embolization of brain arteriovenous malformations: A review of 1246 patients
in 32 series over a 35-year period. Neurosurg, 37(6):1031-1040, Dec 1995.
4. Gomes, A: Embolization therapy of congenital arteriovenous malformations:
Use of alternative approaches. Radiology, 190:191-8, Jan 1994.
5. Terada, T; Kinoshita, Y; Yokote, H; Tsuura, M; Itakura, T; Komai, N; Nakamura,
Y; Tanaka, S; Kuriyama, T: Preoperative embolization of meningiomas fed by
ophthalmic branch arteries. Surg Neurol, 45:161-6, 1996.
Information on packaging:
Symbol
Designation
Manufacturer: Name & Address
Use by date: year-month
LOT
Batch code
REF
Catalogue number
STERILIZE
2
2
Do not resterilize
STERILIZE
2
2
Do not use if package is damaged
STERILIZE
2
2
Keep away from sunlight
STERILIZE
2
2
Keep dry
STERILIZE
2
2
Do not re-use
STERILIZE
2
2
Caution - Refer to Instructions For Use
STERILIZE
2
2
Non-pyrogenic
STERILE
Sterilized using steam
0°C
Lower limit of temperature
Distributed in USA by:
Merit Medical Systems, Inc.
Customer Service
1-800-356-3748
All serious or life-threatening adverse events or deaths
associated with use of Embosphere Microspheres should be
reported to the U.S. Food and Drug Administration under
the MedWatch program and to the device manufacturer.
Information about the MedWatch program and forms for
reporting adverse events can be obtained at www.fda.
gov/safety/medwatch/howtoreport/ucm053074.htm or by
calling toll free 888-463-6332. Reports to Merit Medical, Inc.
can be made by calling toll free 800-394-0295
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