ACUFEX /DIRECTOR ELITE 72202437

GUDID 03596010621979

TRAY ACUFEX ELITE ANATOMIC ACL SYSTEM

Smith & Nephew, Inc.

Instrument tray

• Primary Device ID: 03596010621979
• NIH Device Record Key: c692816a-f2eb-4179-84a1-b551dc59b2af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUFEX /DIRECTOR ELITE
• Version Model Number: 72202437
• Catalog Number: 72202437
• 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: 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: false
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010621979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090562

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

[03596010621979]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

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• 00885556915257 - NA: 2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT
• 00885556915264 - NA: 2025-12-30 EM TIBIA ALIGNMENT TUBE MICRO SHORT
• 00885556915271 - NA: 2025-12-30 MACRO EM TIBIA ALIGNMENT TUBE SHORT
• 00885556915295 - NA: 2025-12-30 RM/LL TIBIA ALIGNMENT GUIDE SHORT
• 00885556915301 - NA: 2025-12-30 TIBIA ALIGNMENT ADJUSTMENT GUIDE SHORT
• 00885556915318 - NA: 2025-12-30 SYNC SHORT EXTRAMEDULLARY GUIDES MODULE
• 00885556900260 - TRIGEN MAX: 2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI