HARMONY 74032502

GUDID 00885556758632

S+N MACRO GUIDE TIBIAL MODULE

Smith & Nephew, Inc.

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00885556758632
• NIH Device Record Key: 8f9ac0c4-a00c-4661-ae1a-95e39e915ea3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARMONY
• Version Model Number: 74032502
• Catalog Number: 74032502
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00885556758632 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

[00885556758632]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [HARMONY]

• 00885556758632: S+N MACRO GUIDE TIBIAL MODULE
• 00885556758625: S+N STANDARD DISTAL FEMORAL MODULE
• 00885556758618: S+N ADJUSTABLE DISTAL FEMORAL MODULE
• 00885556758649: S+N MICRO TIBIAL MODULE
• 00885556735480: EM TIBIAL ALIGNMENT TUBE MACRO
• 00885556735473: EM POSTERIOR SLOPE GUIDE
• 00885556735336: TIBIAL CUTTING GUIDE THREE DEG RIGHT
• 00885556735282: IM ROD SHORT
• 00885556735572: ANKLE CLAMP
• 00885556735459: TIBIAL STYLUS ADJUSTABLE FOOTED
• 00885556735435: TIBIAL CUTTING GUIDE THREE DEG SYMM
• 00885556735329: TIBIAL CUTTING GUIDE THREE DEG LEFT
• 00885556735442: TIBIAL CUTTING GUIDE FIVE DEG SYMM
• 00885556735428: TIBIAL CUTTING GUIDE ZERO DEG SYMM
• 00885556735350: TIBIAL CUTTING GUIDE FIVE DEG RIGHT
• 00885556735343: TIBIAL CUTTING GUIDE FIVE DEG LEFT
• 00885556788448: S+N MODULAR TIBIAL TRIAL AND PREP MODULE
• 00885556788196: S+N JOURNEY II INSERT TRIALS MODULE
• 00885556788189: S+N HALF TRAY LID
• 00885556788172: S+N HALF OUTER TRAY
• 00885556788042: S+N LEGION PRIMARY TRIALING MODULE
• 00885556787854: S+N LEGION MODULAR FEMORAL FINISHING MODULE
• 00885556787830: S+N JOURNEY II MODULAR FEMORAL FINISHING MODULE
• 00885556787809: S+N MODULAR GENERAL INSTRUMENTS MODULE
• 00885556787755: S+N FIXED FEMORAL ALIGNMENT MODULE
• 00885556787724: S+N ADJUSTABLE FEMORAL ALIGNMENT MODULE
• 00885556735565: TIBIAL CUTTING GUIDE HEAD FIVE DEG RIGHT
• 00885556735558: TIBIAL CUTTING GUIDE HEAD FIVE DEG LEFT
• 00885556735541: TIBIAL CUTTING GUIDE HEAD THREE DEG RIGHT
• 00885556735534: TIBIAL CUTTING GUIDE HEAD THREE DEG LEFT
• 00885556735503: EM TIBIAL ALIGNMENT TUBE LEGACY
• 00885556735497: EM TIBIAL ALIGNMENT TUBE MICRO
• 00885556735466: TIBIAL STYLUS 2 AND 10MM PEGGED
• 00885556735299: EM ALIGNMENT GUIDE HANDLE
• 00885556735244: SIX DEGREE VALGUS BUSHING
• 00885556735220: FOUR DEGREE VALGUS BUSHING
• 00885556735183: DISTAL CUT VALGUS GUIDE BRIDGE FIXED
• 00885556735169: DISTAL CUT VALGUS GUIDE
• 00885556758656: S+N TKA ALIGNMENT MODULE
• 00885556744536: POROUS PATELLA TRAY
• 00885556735527: EM TIBIAL ALIGNMENT GUIDE MICRO HEAD
• 00885556692011: 3.2MM X 110MM NON RIMMED DRILL SPEED PIN
• 00885556692004: 3.2MM X 75MM NON RIMMED TROCAR SPEED PIN
• 00885556691991: MIS 3.2MM X 65MM RIMMED PIN STERILE
• 00885556691984: MIS 3.2MM X 45MM RIMMED PIN STERILE
• 00885556691977: MIS 3.2MM X 30MM RIMMED PIN STERILE
• 00885556748169: RESECTION CHECK
• 00885556747995: 25MM SPACER PLATE SHIM
• 00885556747988: 21MM SPACER PLATE SHIM
• 00885556747971: 18MM SPACER PLATE SHIM