HEX-FIX 112722

GUDID 03596010042347

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03596010042347
• NIH Device Record Key: 468112e7-7898-419d-8897-9277000d1817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEX-FIX
• Version Model Number: 112722
• Catalog Number: 112722
• Company DUNS: 045483575
• 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: false
• 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)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	03596010042347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994143

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2017-11-13

On-Brand Devices [HEX-FIX]

• 03596010512826: STAINLESS STEEL HALF PIN 5MM X 50MM
• 03596010512819: STAINLESS STEEL HALF PIN 5MM X 45MM
• 03596010512802: STAINLESS STEEL HALF PIN 5MM X 40MM
• 03596010512796: STAINLESS STEEL HALF PIN 5MM X 35MM
• 03596010512789: STAINLESS STEEL HALF PIN 5MM X 30MM
• 03596010069870: STAINLESS STEEL HALF PIN 6MM X 60MM
• 03596010069863: STAINLESS STEEL HALF PIN 6MM X 50MM
• 03596010069856: STAINLESS STEEL HALF PIN 6MM X 40MM
• 03596010069719: STAINLESS STEEL HALF PIN 5MM X 25MM
• 03596010069702: STAINLESS STEEL HALF PIN 5MM X 20MM
• 03596010069580: TITANIUM HALF PIN 6.0MM X 60MM
• 03596010069573: TITANIUM HALF PIN 6.0MM X 50MM
• 03596010069566: TITANIUM HALF PIN 6.0MM X 40MM
• 03596010069535: TITANIUM HALF PIN 5.0MM X 80MM
• 03596010069498: TITANIUM HALF PIN 5.0MM X 60MM
• 03596010069481: TITANIUM HALF PIN 5.0MM X 55MM
• 03596010069474: TITANIUM HALF PIN 5.0MM X 50MM
• 03596010069467: TITANIUM HALF PIN 5.0MM X 45MM
• 03596010069450: TITANIUM HALF PIN 5.0MM X 40MM
• 03596010069443: TITANIUM HALF PIN 5.0MM X 35MM
• 03596010069436: TITANIUM HALF PIN 5.0MM X 30MM
• 03596010069429: TITANIUM HALF PIN 5.0MM X 25MM
• 03596010069412: TITANIUM HALF PIN 5.0MM X 20MM
• 03596010069382: TITANIUM HALF PIN 4.0MM X 40MM
• 03596010069375: TITANIUM HALF PIN 4.0MM X 35MM
• 03596010069368: TITANIUM HALF PIN 4.0MM X 30MM
• 03596010069351: TITANIUM HALF PIN 4.0MM X 25MM
• 03596010069344: TITANIUM HALF PIN 4.0MM X 20MM
• 23596010042402: HEX FIX BAR END CAP
• 03596010042187: HEX-FIX HEX BAR LONG 508MM STAINLESS STEEL
• 03596010171306: HEX-FIX HALF PIN STERILIZATION TRAY
• 03596010042217: HEX-FIX DOUBLE SPOOL WITH RINGS
• 03596010042170: HEX-FIX HEX BAR LONG 508MM ALUMINUM
• 03596010042163: HEX-FIX HEX BAR MEDIUM 406MM ALUMINUM
• 03596010042354: HEX-FIX AMSCO HALL ADAPTOR
• 03596010042231: HEX-FIX METATARSAL PADDLE & CLAMP
• 03596010171290: HEX-FIX FLEX HEAD COMBINATION TOOL
• 03596010171276: HEX-FIX DRILL GUIDE WITH TROCAR
• 03596010171269: HEX-FIX DRIVE UNIT
• 03596010171245: HEX-FIX UNIVERSAL RING ADAPOINTER
• 03596010171160: HEX-FIX SINGLE SWIVEL CLAMP
• 03596010171146: HEX-FIX SINGLE PIN CLAMP
• 03596010042361: HEX-FIX TIGHTENING BAR WITH HANDLE
• 03596010042347: 112722
• 03596010042323: HEX-FIX DEPTH GAUGE
• 03596010042316: HEX-FIX STRAIGHT HEX DRIVER
• 03596010042309: HEX-FIX 90 DEGREE HEX DRIVER
• 03596010042293: HEX-FIX PIN DRIVER/ EXTRACTOR