AzurMeds Inc.

Address:2547 Farrington St.,Dallas,TX,75207,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

Orthopedic Manual Surgical Instrument (LXH) (7) Holder, Needle; Orthopedic (HXK) (2) Guide, Drill, Ligament (LXI) (1)

Premarket Exempt

No Yes

Clear

LTJ - 00810041626325 Catalog Number :

Device Description : LTJ 2.9mm Solid Drill L 270mm for Drill Driver

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXI

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626417 Catalog Number :

Device Description : LTJ Drill Guide

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

LTJ - 00810041626424 Catalog Number :

Device Description : LTJ Drill Guide Handle

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

LTJ - 00810041626431 Catalog Number :

Device Description : LTJ Glenoid Drill Guide

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

LTJ - 00810041626448 Catalog Number :

Device Description : LTJ Double Drill Guide - Base

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626455 Catalog Number :

Device Description : LTJ Modular Drill Guide - 9 mm

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626462 Catalog Number :

Device Description : LTJ Modular Drill Guide - 11 mm

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626479 Catalog Number :

Device Description : LTJ Modular Drill Guide - 13 mm

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626516 Catalog Number :

Device Description : LTJ Coracoid Preparation Clamp - Left

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626523 Catalog Number :

Device Description : LTJ Coracoid Preparation Clamp - Right

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : Yes

Device Count : 1

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