Lockdown Medical Ltd

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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

Instrument, Manual, Surgical, General Use (MDM) (5) Guide, Drill, Ligament (LXI) (1) Guide, Surgical, Instrument (FZX) (1) Screwdriver (HXX) (1) Screwdriver, Surgical (LRZ) (1) Tap, Bone (HWX) (1) Tape, Measuring, Rulers And Calipers (FTY) (1) Bit, Drill (HTW) (1) Washer, Bolt Nut (HTN) (1)

Premarket Exempt

No Yes

Clear

AC DEVICE - 05060433600302 Catalog Number : LDSS40

Device Description : 40mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)

Device Class : 2

Duns Number: 211167885

Premarket Exempt : No

Product Code : HTN

Prescription Use : Yes

Device Count : 1

AC DEVICE - 05060433600319 Catalog Number : LDIN627/S

Device Description : Lockdown AO Drill 2.5mm diameter (Sterile)

Device Class : 1

Duns Number: 211167885

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

AC DEVICE - 05060433600326 Catalog Number : LDIN628/S

Device Description : Lockdown AO Cortical Tap 3.5mm diameter (Sterile)

Device Class : 1

Duns Number: 211167885

Premarket Exempt : No

Product Code : HWX

Prescription Use : Yes

Device Count : 1

AC DEVICE - 05060433600333 Catalog Number : LDLG

Device Description : LockDown Acromioclavicular (AC) Length Gauge

Device Class : 1

Duns Number: 211167885

Premarket Exempt : No

Product Code : FTY

Prescription Use : Yes

Device Count : 1

LSSS - 05060433600692 Catalog Number : IN414

Device Description : Lockdown Angled Intrducer for use on right shoulder - single use

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

LSSS - 05060433600708 Catalog Number : IN413

Device Description : Lockdown Angled Introducer for use on left shoulder - single use

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

LSSS - 05060433600715 Catalog Number : IN412

Device Description : Lockdown Loop Tensioner - Single Use

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

AC DEVICE - 05060433600753 Catalog Number : INSUL

Device Description : Left Shoulder Single Use Instrument Pack

Device Class :

Duns Number: 211167885

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

LSSS - 05060433600777 Catalog Number : RM04051

Device Description : AO SCREWDRIVER SHAFT Ø2.5MM (HEX). THE FINISHED PART NUMBER IS IN629/1 - "AO SCR AO SCREWDRIVER SHAFT Ø2.5MM (HEX). THE FINISHED PART NUMBER IS IN629/1 - "AO SCREWDRIVER SHAFT Ø2.5MM (HEX) - RM04051"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM, LRZ, HXX

Prescription Use : No

Device Count : 1

LSSS - 05060433600807 Catalog Number : RM04053

Device Description : DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm. THE FINISHED PART NUMBER IS IN631/1 - " DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm. THE FINISHED PART NUMBER IS IN631/1 - "DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm - RM04053"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM, FZX, LXI

Prescription Use : No

Device Count : 1

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