Bard Brachytherapy, Inc.

Address:295 E. LIES RD.,CAROL STREAM,IL,60188,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

Source, brachytherapy, radionuclide (KXK) (10)

Premarket Exempt

No Yes

Clear

Bard® BrachySource® I-125 Implant Seed - 00801741078194 Catalog Number : PS1251L

Device Description : BrachySource® I125 Loose Seeds, Non-Sterile

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seed - 00801741078200 Catalog Number : PS1251LS

Device Description : BrachySource® I125 Loose Seeds, Sterile

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078217 Catalog Number : PS1251C

Device Description : BrachySource® I125 SEEDS IN MICK CRTDG, NON-STERILE

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078224 Catalog Number : PS1251CS

Device Description : BrachySource® I125 SEEDS IN MICK CRTDG, STERILE

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078231 Catalog Number : PS1251CN

Device Description : BrachySource® I125 SEEDS IN MICK CRTDG, STERILE W/ PRELD NEEDLES

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078248 Catalog Number : 1251CSF

Device Description : BrachySource® I125 SEEDS LOADED W SourceCaps™ IN MICK CRTDG, STERILE

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078255 Catalog Number : 1251CNF

Device Description : BrachySource® I125 SEEDS LOADED W SourceCaps™ IN MICK CRTDG, STERILE W PRELOADED NEEDLES

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078262 Catalog Number : 1251CSR

Device Description : BrachySource® I125 Seeds loaded in Reusable Mick magazine, STERILE

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078279 Catalog Number : 1251CSRA

Device Description : BrachySource® I125 SEEDS IN MICK DISPOSABLE 15, STERILE FOR ASSAY

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Bard® BrachySource® I-125 Implant Seeds In Cartridges - 00801741078286 Catalog Number : 1251CSRAF

Device Description : BrachySource® I125 SEEDS IN MICK SourceCaps™ MAG, STERILE FOR ASSAY

Device Class : 2

Duns Number: 185524860

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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