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) (3) Gauge, Depth (HTJ) (2) Holder, Needle; Orthopedic (HXK) (2) Retractor (GAD) (2)

Premarket Exempt

No Yes

Clear

LTJ - 00810041626530 Catalog Number :

Device Description : LTJ Coracoid Preparation Clamp - Straight

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626608 Catalog Number :

Device Description : LTJ Graft Positioning & Drilling Gun

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626615 Catalog Number :

Device Description : LTJ Graft Positioning & Drilling Gun - Indexing Jaw

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626622 Catalog Number :

Device Description : LTJ Graft Positioning & Drilling Gun - Supporting Jaw

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626813 Catalog Number :

Device Description : LTJ Baxter Retractor

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626820 Catalog Number :

Device Description : LTJ Modifed Trillat Retractor

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LTJ - 00810041626912 Catalog Number :

Device Description : LTJ Depth Gauge

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : No

Device Count : 1

LTJ - 00810041626929 Catalog Number :

Device Description : LTJ Screw Holder

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : No

Device Count : 1

LTJ - 00810041626936 Catalog Number :

Device Description : LTJ Depth Gauge

Device Class : 1

Duns Number: 117700483

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

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