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Focus Surgery, Inc.

United States·US-MF-000012164

Last updated September 17, 2026

Information

Country: United States
Address: 4000, Pendleton Way, Indianapolis, United States
Website: sonablate.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: —
EUDAMED SRN: US-MF-000012164
FDA FEI Number: 3002132857
DUNS Number: 101084143

Catalogue (15)

Device	Model / Reference	Registries	Class	Status
Sonablate Insertion Pack	403-02200-0002	FDA UDI	N/A	Active
Sonachill	102-17000-0007	FDA UDI	Class II	Active
Water Path Kit	E01020AST61	FDA UDI	N/A	Active
Sonablate Insertion Pack	403-02200-0014	FDA UDI	Class II	Active
Sonablate Insertion Pack	403-02200-0002-BG	FDA UDI	N/A	Active
Water Path Kit	403-02200-0020	FDA UDI	N/A	Active
Sonasource	102-17000-0009	FDA UDI	Class II	Active
Sonablate	202-17000-0012	FDA UDI	Class II	Active
Sonablate	Sonablate	EUDAMEDFDA UDI	Class IIb	Active
Sonablate Insertion Pack	404-14500-0003	EUDAMEDFDA UDI	Class I	Active
O-Ring Applicator Tool	302-08119-1002	EUDAMEDFDA UDI	Class I	Active
Water Path Kit	411-12017-0001	EUDAMEDFDA UDI	Class I	Active
Sonablate Insertion Pack	404-13500-0001	EUDAMEDFDA UDI	Class I	Active
Water Path Kit	E01017AST61	EUDAMEDFDA UDI	Class I	Active
Therasonic Lithotripsy Treatment System	P890066	FDA PMA	Class II	Active

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