CORE LABS, LLC

Address:3720 SOUTH LIPAN ST.,ENGLEWOOD,CO,80110,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

Table, Radiographic, Stationary Top (IXQ) (3) Tube Mount, X-Ray, Diagnostic (IYB) (2) Holder, Radiographic Cassette, Wall-Mounted (IXY) (1)

Premarket Exempt

Yes

Clear

atlas - 00863897000306 Catalog Number : 05000

Device Description : Elevating Radiographic Patient Table HXVF

Device Class : 2

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : No

Device Count : 1

aries - 00863897000313 Catalog Number : 04000

Device Description : Non-Elevating Radiographic Patient Table HXVF

Device Class : 2

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : No

Device Count : 1

aries - 00863897000320 Catalog Number : 04000

Device Description : Non-Elevating Radiographic Patient Table HXVF

Device Class : 2

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : No

Device Count : 1

halo - 00863897000344 Catalog Number : 02000

Device Description : tube mount, x-ray, diagnostic HQNR

Device Class : 1

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : No

Device Count : 1

triton - 00863897000351 Catalog Number : 09000

Device Description : tube mount, x-ray, diagnostic PVGD

Device Class : 1

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IYB

Prescription Use : No

Device Count : 1

flora - 00863897000368 Catalog Number : 08000

Device Description : Radiographic Wall Cassette Holder XDTG

Device Class : 1

Duns Number: 622766397

Premarket Exempt : Yes

Product Code : IXY

Prescription Use : No

Device Count : 1

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