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

Guide, Drill, Ligament (LXI) (5) Screw, Fixation, Bone (HWC) (2) Screwdriver (HXX) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

LTJ - 00810041623607 Catalog Number :

Device Description : LTJ 4.5mm Cannulated Ti Screw L. 45mm Non Sterile

Device Class : 2

Duns Number: 117700483

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

LTJ - 00810041623638 Catalog Number :

Device Description : LTJ 4.5mm Cannulated Ti Screw L. 50mm Non Sterile

Device Class : 2

Duns Number: 117700483

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626103 Catalog Number :

Device Description : LTJ Screwdriver Handle

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

LTJ - 00810041626110 Catalog Number :

Device Description : LTJ Solid Screwdriver Bit

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

LTJ - 00810041626127 Catalog Number :

Device Description : LTJ Solid Screwdriver Bit

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626219 Catalog Number :

Device Description : LTJ 2.3mm Solid Drill L 185mm AO Non Sterile

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXI

Prescription Use : No

Device Count : 1

LTJ - 00810041626226 Catalog Number :

Device Description : LTJ 2.9mm Solid Drill L 185mm AO Non Sterile

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXI

Prescription Use : No

Device Count : 1

LTJ - 00810041626233 Catalog Number :

Device Description : LTJ Cortical Solid Drill L 150mm with Small AO

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXI

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626301 Catalog Number :

Device Description : LTJ Drill Driver

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXI

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626318 Catalog Number :

Device Description : LTJ 2.3mm 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

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