PRECISION DYNAMICS CORPORATION

Address:25124 Springfield Court,Valencia,CA,91355,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

Drape, Surgical, Exempt (PUI) (6) Surgical Table Cushion (LWG) (2) Device, Paste-On For Incontinence, Non-Sterile (NOA) (1) Device, Paste-On For Incontinence, Sterile (EXI) (1)

Premarket Exempt

Yes

Clear

UR-Assure - 10687225301852 Catalog Number :

Device Description : Pediatric Urine Collectors, Sterile, 160MIL

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : EXI

Prescription Use : No

Device Count : 50

UR-Assure - 10687225301876 Catalog Number :

Device Description : Pediatric Urine Collectors, 160MIL, Clean (non-sterile), 50 Qty

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 50

Gantry Guard - 10687225325087 Catalog Number :

Device Description : GANTRY GUARD CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 25

Gantry Guard - 10687225488560 Catalog Number :

Device Description : Sample Pack - GANTRY GUARD™ CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 2 Sample Pack - GANTRY GUARD™ CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR, 3/pack

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 3

Gantry Guard Flex - 10687225648889 Catalog Number : CTG02

Device Description : Gantry Guard Flex, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 170 x 82 inc Gantry Guard Flex, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 170 x 82 inches, Clear, 15/Box

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 15

Gantry Guard Flex Mini - 10687225677865 Catalog Number : CTG03

Device Description : Gantry Guard Flex Mini also called Gantry Guard Mini -- CT Gantry Cover with Adh Gantry Guard Flex Mini also called Gantry Guard Mini -- CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 109 x 82 inches, Clear, 25/Bx

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 25

Gantry Guard Flex - 10687225704615 Catalog Number :

Device Description : Sample Pack - Gantry Guard Flex, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE Sample Pack - Gantry Guard Flex, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 170 x 82 inches, Clear, 3/pack

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 3

Gantry Guard Flex Mini - 10687225704622 Catalog Number :

Device Description : Sample Pack - Gantry Guard Flex Mini, CT Gantry Cover with Adhesive Tabs, 1.6mil Sample Pack - Gantry Guard Flex Mini, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 109 x 82 inches, Clear, 3/pack

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 3

Comfort Cushion - 10687225786512 Catalog Number :

Device Description : Mammography Cushion, Large 29cm x 30cm

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 25

Comfort Cushion - 10687225786529 Catalog Number :

Device Description : Mammography Cushion, Medium, 25cmx29cm

Device Class :

Duns Number: 008486367

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 25

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