Beekley Corporation

Address:1 PRESTIGE LN,Bristol,CT,06010,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, X-Ray, Film Marking, Radiographic (JAC) (9) Container, Specimen, Non-Sterile (NNI) (1)

Premarket Exempt

No Yes

Clear

MR-SPOT - 00815137020100 Catalog Number :

Device Description : MRI Skin Markers for Thoracic Spines, Larger Areas of Interest, 3.0cm Radiance filled tube

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

MR-SPOT - 00815137020117 Catalog Number :

Device Description : MRI Skin Markers for Extremities and Soft Tissue Masses, 1.5cm Radiance filled tube

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

CT-SPOT - 00815137020124 Catalog Number :

Device Description : CT Simulation Skin Markers for Multiple Slice Visibility, 2x2cm non-metallic crosshair

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 50

PinPoint - 00815137020131 Catalog Number :

Device Description : Multi-Modality Fiducial Markers for CT/MRI Image Registration, 1.27mm diameter center hole

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 30

MR-SPOT - 00815137020148 Catalog Number :

Device Description : MRI Skin Markers for Thoracic Spines, Larger Areas of Interest, 5.0cm Radiance f MRI Skin Markers for Thoracic Spines, Larger Areas of Interest, 5.0cm Radiance filled packet

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

MR-SPOT - 00815137020155 Catalog Number :

Device Description : MRI Skin Markers for Extremities and Soft Tissue Masses, 1.75cm Radiance filled packet

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

OrthoSPOTS Packets - 00815137020162 Catalog Number :

Device Description : MRI Skin Markers for Orthopedic Imaging, 0.75cm Radiance filled packet

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

PinPoint - 00815137020179 Catalog Number :

Device Description : MRI Skin Markers for Small Field of View Imaging, 6mm Radiance filled inner diameter

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

Localizers - 00815137020186 Catalog Number :

Device Description : Diagnostic CT Skin Markers, 2.3mm low-density pellet

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 40

AccuGrid - 00815137020193 Catalog Number :

Device Description : Disposable Specimen Radiography System with Localizing Grid, 5.65" radiolucent grid

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : No

Device Count : 10

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