RADIOMED CORP

Address:3150 Stage Post Drive, Suite 106,Bartlett,TN,38133,US

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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

Accelerator, Linear, Medical (IYE) (7) Source, Brachytherapy, Radionuclide (KXK) (3) System, X-Ray, Tomography, Computed (JAK) (2)

Premarket Exempt

Clear

VISICOIL MR - EIBASNMR03502022200 Catalog Number : SNMR-035-020-2220

Device Description : 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE, JAK

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR03503022200 Catalog Number : SNMR-035-030-2220

Device Description : 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE, JAK

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR05000521080 Catalog Number : SNMR-050-005-2108

Device Description : 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR05000521150 Catalog Number : SNMR-050-005-2115

Device Description : 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR05000521200 Catalog Number : SNMR-050-005-2115

Device Description : 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR05001021150 Catalog Number : SNMR-050-005-2115

Device Description : 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

VISICOIL MR - EIBASNMR05001021200 Catalog Number : SNMR-050-005-2120

Device Description : 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

VISICOIL - EIBATL050215200 Catalog Number : TL-050-21520

Device Description : 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

VISICOIL - EIBATL050620200 Catalog Number : TL-050-62020

Device Description : 2 - 0.50mm x 0.5cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loade 2 - 0.50mm x 0.5cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

VISICOIL - EIBATL07501518120 Catalog Number : TL-075-01518-12

Device Description : 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) load 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 18 gauge pre-waxed brachytherapy needle 12cm in length.

Device Class : 2

Duns Number: 036545713

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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