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) (10)

Premarket Exempt

No Yes

Clear

Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - 00815568020007 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 Barrel Ovoid Applicator Set (E) - 00815568020014 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 Cylinder Ovoid Applicator Set (E) - 00815568020021 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) - 00815568020038 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Tandem and 60 Deg Ring Applicator Set (E) - 00815568020045 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Tandem and 45 Deg Ring Applicator Set (E) - 00815568020052 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Tandem and 30 Deg Ring Applicator Set (E) - 00815568020069 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 (E) - 00815568020076 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Prostate HDR Template - 16 ga/5 Fr - 00815568020090 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

Kobold® Prostate HDR Template - 17 ga/4 Fr - 00815568020106 Catalog Number :

Device Class : 2

Duns Number: 014292258

Premarket Exempt : No

Product Code : JAQ

Prescription Use : Yes

Device Count : 1

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