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 - 00850020470112 Catalog Number :

Device Description : 1" Dia. Al Spot Source Co-57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470129 Catalog Number :

Device Description : 1" Dia. Spot Source Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470136 Catalog Number :

Device Description : 1" Dia. Left Right Markers Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470143 Catalog Number :

Device Description : 1" Dia. Al Spot Source Ge-68

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470150 Catalog Number :

Device Description : 1" Dia. Spot Source Ge-68 NIST calibrated

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470167 Catalog Number :

Device Description : 1" Dia. Spot Source Ge-68

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470174 Catalog Number :

Device Description : 1" Dia. Spot Source Ba-133

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470181 Catalog Number :

Device Description : BA-133 "E" Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470198 Catalog Number :

Device Description : Cs-137 "E" Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470204 Catalog Number :

Device Description : Co 57 "E" Vial

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

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