RADQUAL, 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

Source, Calibration, Sealed, Nuclear (IXD) (10)

Premarket Exempt

Yes

Clear

RadQual - 00850020470310 Catalog Number :

Device Description : Ge 68 5cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470327 Catalog Number :

Device Description : Ba-133 10cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470334 Catalog Number :

Device Description : Cs-137 10cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470341 Catalog Number :

Device Description : Co-57 10cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470358 Catalog Number :

Device Description : Co 60 10cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470365 Catalog Number :

Device Description : Ge 68 10cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470372 Catalog Number :

Device Description : Ba-133 20cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470389 Catalog Number :

Device Description : Cs-137 20cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470396 Catalog Number :

Device Description : Co-57 20cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470402 Catalog Number :

Device Description : Co 60 20cc Multidose Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

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