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Crédits
Devices
Urologix Targis System, Coolant Bag
Modèle / numéro de série
Catalog # / Lot No. PT1034 / AHP0333111A, AHP040411A, AHP040411B, AHP040611A, AHP040711A, AHP040811A, AHP041211A PT1036 / ACP033011B, ACP040111A, ACP040111B, ACP040611A, ACP040711A, ACP040711B, ACP040811A, ACP041211A PT1038 / ALP033111A, ALP040411A PT1013 / KP040711A CA1111B / C900284, C900285 and C900286 C900284, C900285 and C900286 C900284 and C900285 C900285
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
3
Dispositif implanté ?
No
Distribution
Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.
Description du dispositif
The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.
Manufacturer
Urologix, Inc.
1 Event
Rappel de Urologix Targis System, Coolant Bag
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Fabricant
Urologix, Inc.
Adresse du fabricant
Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
Source
USFDA
Language
English
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