APTIS MEDICAL, LLC

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

Bit, Drill (HTW) (5) Prosthesis, Wrist, Hemi-, Ulnar (KXE) (3) Guide, Surgical, Instrument (FZX) (1) Screwdriver (HXX) (1)

Premarket Exempt

No Yes

Clear

Scheker DRUJ - B013DRUJAW150 Catalog Number : DRUJAW15

Device Description : 1.5mm Hex Head Allen Wrench

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

NA - B013DRUJB10200 Catalog Number : DRUJ-B1020

Device Description : Distal Radioulnar Joint Ball Size 10 or Size 20

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJB200 Catalog Number : DRUJ-B20

Device Description : UHMWP Ball, 9.5 mm, Size 20

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJB250 Catalog Number : DRUJ-B25

Device Description : 2.5mm Quick Connect Drill Bit

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

NA - B013DRUJB300 Catalog Number : DRUJ-B30

Device Description : UHMWP Ball, 11 mm, Size 30

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJCB0400 Catalog Number : DRUJ-CB040

Device Description : Cannulated Drill Bit 4.0mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJCB0450 Catalog Number : DRUJ-CB045

Device Description : Cannulated Drill Bit 4.5mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJCB0500 Catalog Number : DRUJ-CB050

Device Description : Cannulated Drill Bit 5.0mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJCB0600 Catalog Number : DRUJ-CB060

Device Description : Cannulated Drill Bit 6.0mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJD1000 Catalog Number : DRUJ-D100

Device Description : 2.5mm Drill Guide

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

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