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) (10)

Premarket Exempt

No Yes

Clear

N-SPOT - 00815137020407 Catalog Number :

Device Description : Nipple Markers, 2.0mm lead-free pellet, extended side tabs and adhesive-free center

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 110

Altus - 00815137020414 Catalog Number :

Device Description : Point of Pain/Non-Palpable Area of Concern Markers, uniform low-density see-through square

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 60

S-SPOT - 00815137020421 Catalog Number :

Device Description : Scar Markers, 1mm diameter uniform low-density see-through line, pinch free material

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 280

N-SPOT - 00815137020438 Catalog Number :

Device Description : Nipple Markers, 2.5mm lead-free pellet, pinch free material with adhesive-free center

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 94

O-SPOT - 00815137020445 Catalog Number :

Device Description : Mole Markers, 1mm uniform low-density see-through ring, pinch free material

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 55

V-SPOT - 00815137020452 Catalog Number :

Device Description : Nipple Markers, 2.3mm non-metallic pellet

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 130

N-SPOT - 00815137020469 Catalog Number :

Device Description : Nipple Markers, 2.3mm non-metallic pellet, extended side tabs and adhesive-free center

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 110

S-SPOT - 00815137020476 Catalog Number :

Device Description : Scar Markers, 1mm diameter uniform ultra-sheer see-through line, pinch free material

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 280

TomoSPOT - 00815137020483 Catalog Number :

Device Description : Nipple Markers, 2.3mm non-metallic pellet, pinch-free material with adhesive free center

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 92

TomoSPOT - 00815137020490 Catalog Number :

Device Description : Mole Markers, low-density see-through ring, pinch-free material

Device Class :

Duns Number: 001157841

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 54

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