CDR Systems Inc

Address:4334 - 110 Ave SE,Calgary Alberta,CA

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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

Accelerator, Linear, Medical (IYE) (10)

Premarket Exempt

Clear

Index Bar - 00628341930154 Catalog Number : IB06-K

Device Description : Index Bar (MR Conditional)

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Vacuum Lock - 00628341930161 Catalog Number : VB

Device Description : Vacuum Lock Cushion

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930178 Catalog Number : SB02

Device Description : Freedom 6 Couch Extension Head & Neck

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930185 Catalog Number : SB02-S1

Device Description : Freedom 6 Couch Extension Cranial

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930192 Catalog Number : SB02-ST

Device Description : Freedom 6 Couch Extension, S-Type

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930208 Catalog Number : BM02-T

Device Description : Roll Adapter

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Freedom - 00628341930215 Catalog Number : COMP-KIT

Device Description : Compression Belt

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Thermoplastic - 00628341930222 Catalog Number :

Device Description : Thermoplastic Immobilization Materials

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Positioning Aids - 00628341930239 Catalog Number : THS03

Device Description : Cranial Head Support

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Table Pads - 00628341930246 Catalog Number : TP

Device Description : Table Pad

Device Class : 2

Duns Number: 206950904

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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