Kubtec

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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

Probe, Uptake, Nuclear (IZD) (8) System, X-Ray, Mobile (IZL) (1) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

GammaPro Carry Case and Tablet - B619GPROCASETABL2 Catalog Number :

Device Description : Table with installed software is used with wireless battery powered probes (diff Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Hi-Sense Probe with Tablet and Carry Case - B619GPROHISKIT0 Catalog Number :

Device Description : GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing ra GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro High Sensitivity Probe - B619GPROHISPROBE0 Catalog Number :

Device Description : GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Laparoscopic Probe with Tablet and Carry Case - B619GPROLAPKIT0 Catalog Number :

Device Description : GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizin GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Laparoscopic Probe - B619GPROLAPPROBE0 Catalog Number :

Device Description : GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Angled Standard Probe - B619GPROSTDANGPROBE0 Catalog Number :

Device Description : GammaPro Angled Standard Probe used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Standard Probe with Tablet Carry Case - B619GPROSTDKIT0 Catalog Number :

Device Description : GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizi GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

GammaPro Straight Standard Probe - B619GPROSTDPROBE0 Catalog Number :

Device Description : GammaPro Straight Standard Probe for wireless ionizing radiation detection.

Device Class : 1

Duns Number: 361955128

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

KUBTEC - B619KUB2500 Catalog Number :

Device Description : mobile x-ray system

Device Class : 2

Duns Number: 361955128

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

KUBTEC - B619X200 Catalog Number :

Device Description : specimen x-ray system

Device Class : 2

Duns Number: 361955128

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

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