Lockdown Medical Ltd

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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) Gauge, Depth, Instrument, Dental (EIL) (3) Gauge, Depth (HTJ) (3) Tray, Surgical, Instrument (FSM) (2) Screwdriver (HXX) (2) Screwdriver, Surgical (LRZ) (2) Tray, Surgical (LRP) (2)

Premarket Exempt

No Yes

Clear

LSSS - 05060433600845 Catalog Number : RM04953

Device Description : LOCKDOWN (LSSS) SURGICAL TRAY BASE WHICH HOUSES ALL INSTRUMENTS REQUIRED FOR THE LOCKDOWN (LSSS) SURGICAL TRAY BASE WHICH HOUSES ALL INSTRUMENTS REQUIRED FOR THE LOCKDOWN SHOULDER STABILISATION PROCEDURE. tHIS TRAY ALSO HAS A LID (DI NO#: 05060433600920) ASSOCIATED WITH IT THAT LOCKS INTO PLACE. TRAY BASE SUPPLIED BY RUDISCHHAUSER.

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : FSM, LRP

Prescription Use : No

Device Count : 1

AC DEVICE - 05060433600869 Catalog Number : INSUR

Device Description : Right Shoulder Single Use Instrument Kit

Device Class :

Duns Number: 211167885

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

LSSS - 05060433600876 Catalog Number : RM06006

Device Description : AO CANNULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING. THE "AO SCREWDRIV AO CANNULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING. THE "AO SCREWDRIVER SPINNER" - DI NO# (05060433600883) SCREWS ONTO THE END OF THIS DEVICE. THIS CREATES THE FINAL INSTRUMENT IN630/1 - "AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : LRZ, HXX, MDM

Prescription Use : No

Device Count : 1

LSSS - 05060433600883 Catalog Number : RM06007

Device Description : AO SCREWDRIVER SPINNER (THIS PART FITS ONTO THE BOTTOM END OF "AO CANULATED SILI AO SCREWDRIVER SPINNER (THIS PART FITS ONTO THE BOTTOM END OF "AO CANULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING, RM06006 - PRIMARY DI NO# (0506433600876)". THIS INSTRUMENT PART ALONG WITH "AO CANULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING" MAKEUP INSTRUMENT IN630/1 - "AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : LRZ, HXX, MDM

Prescription Use : No

Device Count : 1

LSSS - 05060433600890 Catalog Number : RM06010

Device Description : DEPTH GAUGE OUTER BODY CAP. THIS CAP SCREWS ONTO "DEPTH GAUGE OUTER BODY TUBE - DEPTH GAUGE OUTER BODY CAP. THIS CAP SCREWS ONTO "DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433600906)" AND ENCLOSES "DEPTH GAUGE INNER BODY WITH BALL & SPRING - RM06009 (DI NO# 05060433600913)". THIS CREATES THE FINAL INSTRUMENT IN626/1 - "DEPTH GAUGE ASSEMBLY- AS01069 "

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : HTJ, EIL, MDM

Prescription Use : No

Device Count : 1

LSSS - 05060433600906 Catalog Number : RM06008

Device Description : DEPTH GAUGE OUTER BODY TUBE. THIS TUBE HOUSES THE "DEPTH GAUGE INNER BODY WITH DEPTH GAUGE OUTER BODY TUBE. THIS TUBE HOUSES THE "DEPTH GAUGE INNER BODY WITH BALL & SPRING - RM06009 (DI NO# 05060433600913)" AND HAS A CAP THAT FITS ONTO THE END OF IT CALLED "DEPTH GAUGE OUTER BODY CAP - RM06010 (05060433600890)". THIS CREATES THE FINAL INSTRUMENT IN626/1 - "DEPTH GAUGE ASSEMBLY - AS01069"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM, HTJ, EIL

Prescription Use : No

Device Count : 1

LSSS - 05060433600913 Catalog Number : RM06009

Device Description : DEPTH GAUGE INNER BODY WITH BALL & SPRING. THIS INNER TUBE HAS MARKINGS ON IT. I DEPTH GAUGE INNER BODY WITH BALL & SPRING. THIS INNER TUBE HAS MARKINGS ON IT. IT SITS INSIDE THE "DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433906)". THIS CREATES THE FINAL INSTRUMENT IN626/1 - "DEPTH GAUGE ASSEMBLY - AS01069"

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : MDM, HTJ, EIL

Prescription Use : No

Device Count : 1

LSSS - 05060433600920 Catalog Number : RM06005

Device Description : Lockdown (LSSS) Surgical Instrument Metal Tray Lid. This Tray lid attaches to th Lockdown (LSSS) Surgical Instrument Metal Tray Lid. This Tray lid attaches to the Lockdown Tray base (DI NO#: 05060433600845). This lid is supplied by Rudischhauser.

Device Class : 1

Duns Number: 211167885

Premarket Exempt : Yes

Product Code : FSM, LRP

Prescription Use : No

Device Count : 1

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