ILIZAROV SYSTEMS 101365

GUDID 03596010030559

5/8 RING 160MM COMPOSITE

Smith & Nephew, Inc.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 03596010030559
• NIH Device Record Key: 12ffa05c-3820-494f-8b82-9ef5fcfa497b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILIZAROV SYSTEMS
• Version Model Number: 101365
• Catalog Number: 101365
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010030559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994143

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

[03596010030559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

On-Brand Devices [ILIZAROV SYSTEMS]

• 20885556289048: ILIZAROV DRILL TIP WIRE WITH STOPPER 1.8MM X 385MM
• 20885556288997: ILIZAROV DRILL TIP WIRE 1.8MM X 385MM
• 20885556158740: ILIZAROV HALF PIN DISC CLIP 4/5/6MM ORANGE
• 20885556158733: ILIZAROV WIRE DISC CLIP 1.5MM TO 1.8MM GREY
• 00885556147443: LENGTHENING OVER NAIL DRILL GUIDE TRIGEN DROP
• 00885556124543: COMPOSITE FOOT RING 130MM ID X 160MM LENGTH
• 00885556119433: ANGLE PIN CONNECTOR 35MM
• 00885556119426: ANGLE PIN CONNECTOR 85MM
• 00885556119419: EXTENDED CONNECTOR SHORT 30mm
• 00885556119402: EXTENDED CONNECTOR LONG 50mm
• 20885556119390: WIRE FIXATION COMBINATION BOLT
• 20885556119383: RUSSIAN LONG NUT
• 20885556119376: THICK ITALIAN NUT
• 00885556119365: ILIZAROV WIRE TENSIONER ACCESSORY HANDLE
• 00885556119358: FRAME STABILIZER TOOL
• 00885556119174: RATCHET WRENCH 10MM
• 20885556119161: ILIZAROV DRILL TIP WIRE WITH STOPPER 1.8MM X 400MM
• 20885556088467: HALF PIN CAP 6MM ORANGE
• 20885556088450: ILIZAROV DRILL TIP WIRE 1.8MM X 400MM
• 00885556076590: 1.8MM ILIZAROV WIRE W/OLIVE XL 546MM
• 00885556066195: SHORT CONN PLATE 9HL W/OVAL SLOT-105MM
• 00885556065792: SHORT CONN PLATE 8HL W/OVAL SLOT-95MM
• 00885556065716: SHORT CONN PLATE 4HL W/OVAL SLOT-55MM
• 00885556065570: SHORT CONN PLATE 7HL W/OVAL SLOT-85MM
• 00885556065266: SHORT CONN PLATE 3HL W/OVAL SLOT-45MM
• 00885556065037: SHORT CONN PLATE 6HL W/OVAL SLOT-75MM
• 00885556064887: SHORT CONN PLATE 2HL W/OVAL SLOT-35MM
• 00885556064146: SHORT CONN PLATE 10HL W/OVAL SLOT-115MM
• 00885556063989: SHORT CONN PLATE 5HL W/OVAL SLOT-65MM
• 00885556060667: DRILL TIP WIRE CORTICAL 1.8MM DIAMETER 355 MM
• 00885556060643: DRILL TIP WIRE WITH STOPPER 1.8MM DIAMETER 385 MM
• 00885556056561: ILIZAROV BASIC INSTRUMENT TRAY 1
• 00885556055496: ILIZAROV BASIC INSTRUMENT TRAY 2
• 20885556051591: THICK ITALIAN NUT
• 00885556051030: ILIZAROV POST
• 00885556047514: 5/8 RING 260MM DIA. SS
• 00885556047439: 5/8 RING 240MM DIA. SS
• 00885556047316: 5/8 RING 220MM DIA. SS
• 00885556044810: COMPOSITE FOOT RING 200MM ID X 160MM LONG
• 00885556014769: 1.8MM TITANIUM OLIVE WIRE BAYONET POINT
• 00885556014691: 1.8MM TITANIUM WIRE SMOOTH BAYONET POINT
• 00885556013694: ILIZAROV FOOT AND ANKLE EXTERNAL FIXATION BASE
• 00885556013588: FRAME STABILIZER LID
• 00885556013427: HALF-PIN INSTRUMENT CASE
• 00885556013373: WIRE WITH STOPPER 1.5MM DIAMETER 300MM
• 00885556013212: HALF-PIN INSTRUMENT LID
• 00885556013113: ILIZAROV WIRE CADDY
• 00885556012598: ILIZAROV FOOT AND ANKLE EXTERNAL FIXATION MAYO STAND CADDY
• 00885556012420: WIRE CUTTER
• 00885556012307: ILIZAROV FOOT AND ANKLE EXTERNAL FIXATION LID