GALIL MEDICAL INC.

Address:4364 Round Lake Road,Arden Hills,MN,55112,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Ablation, Microwave And Accessories (NEY) (3)

Premarket Exempt

Clear

HEATfx 2.1 15cm Needle - 07290104831157 Catalog Number : FPRPR5102

Device Description : Microwave ablation needle

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

HEATfx 2.1 20cm Needle - 07290104831171 Catalog Number : FPRPR5101-02

Device Description : Microwave ablation needle

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

HEATfx 2.1 15cm Needle - 07290104831188 Catalog Number : FPRPR5102-02

Device Description : Microwave ablation needle

Device Class : 2

Duns Number: 809529469

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

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