KOBOLD, LLC

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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, Applicator, Radionuclide, Remote-Controlled (JAQ) (8) Table, Radiologic (KXJ) (2)

Premarket Exempt

No Yes

Clear

Kobold® Prostate HDR Template - 18 ga - 00815568020113 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr - 00815568020137 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr - 00815568020144 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Prone Breast Board - 00815568020151 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Kobold® Prone Belly Board - 00815568020168 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Kobold® Interstitial Extender Set - 00815568020175 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Fletcher-model Tandem and Ovoid Applicator Set (V) - 00815568020182 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Henschke-model Tandem and Ovoid Applicator Set (V) - 00815568020199 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Vaginal Cylinder Applicator Set (V) - 00815568020205 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Miami Cylinder Applicator Set (V) - 00815568020236 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

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