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

Guide, Surgical, Instrument (FZX) (3) Prosthesis, Wrist, Hemi-, Ulnar (KXE) (2) Tray, Surgical (LRP) (2) Screwdriver (HXX) (1) Tap, Bone (HWX) (1)

Premarket Exempt

Yes No

Clear

NA - B013DRUJSC240 Catalog Number : DRUJ-SC24

Device Description : 24 mm 3.5 Cortical Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJSD1500 Catalog Number : DRUJ-SD15

Device Description : 1.5mm Square Head Bit

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJT350 Catalog Number : DRUJ-T35

Device Description : 3.5mm Quick Connect Tap

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJTDG250 Catalog Number : DRUJ-TDG25

Device Description : 2.5mm Threaded Drill Guide

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJTRPT100 Catalog Number : DRUJ-TRPT10

Device Description : Threaded Radial Plate Trial Sz 10 - 13mm

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJTRPT200 Catalog Number : DRUJ-TRPT20

Device Description : Threaded Radial Plate Trial Sz 20 - 15mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJTRPT300 Catalog Number : DRUJ-TRPT30

Device Description : Threaded Radial Plate Trial Sz 30 - 17mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013MITDRUJ1000 Catalog Number : MITDRUJ-100

Device Description : Metal Instrument Tray, Distal Radioulnar Joint

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013MITINT1000 Catalog Number : MITINT-100

Device Description : Metal Instrument Tray, Interchangeable

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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