APTIS MEDICAL, LLC

Address:3602 Glenview Ave,Glenview,KY,40025,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

Prosthesis, Wrist, Hemi-, Ulnar (KXE) (9) Tray, Surgical (LRP) (1)

Premarket Exempt

Yes No

Clear

NA - B013DRUJS3350 Catalog Number : DRUJ-S3350

Device Description : Distal Radio-Ulnar Joint Stem, Size 30, 3 cm Extended Stem, 5.0 mm Diameter

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJS3450 Catalog Number : DRUJ-S3450

Device Description : Distal Radio-Ulnar Joint Stem, Size 30, 4 cm Extended Stem, 5.0 mm Diameter

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJSB1000 Catalog Number : DRUJ-SB100

Device Description : Instrument Tray, Screw Block

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

NA - B013DRUJSC100 Catalog Number : DRUJ-SC10

Device Description : 10 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC120 Catalog Number : DRUJ-SC12

Device Description : 12 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC140 Catalog Number : DRUJ-SC14

Device Description : 14 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC160 Catalog Number : DRUJ-SC16

Device Description : 16 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC180 Catalog Number : DRUJ-SC18

Device Description : 18 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC200 Catalog Number : DRUJ-SC20

Device Description : 20 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJSC220 Catalog Number : DRUJ-SC22

Device Description : 22 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

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