ELITE 72202202

GUDID 03596010621344

TRAY ELITE PREMIUM BICEPS TENODESIS SYS

Smith & Nephew, Inc.

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• Primary Device ID: 03596010621344
• NIH Device Record Key: 3eda7f58-71ae-42aa-8e4f-01705dfd023c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE
• Version Model Number: 72202202
• Catalog Number: 72202202
• 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
• 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	03596010621344 [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

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

Moist Heat or Steam Sterilization

[03596010621344]

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

On-Brand Devices [ELITE]

• 00885556704134: RFB TRAY ELITE HIP SYSTEM
• 00885556659304: REFURBISHED TRAY ELITE PREMIUM BICEPS TS
• 00885556572856: REFURBTRAY ELITE PRMIUM INSTAB SYS
• 00885556572849: REFURB TRAY ELITE PRMIUM II SHLDR SYS
• 00885556504710: REFURB.ELITE PREMIUM KNOT MANIPULATOR
• 03596010621801: TRAY ELITE PRMIUM II SHLDR ARTHRO SYS
• 03596010621795: TRAY ELITE PRMIUM INSTABILITY SYSTEM
• 03596010621344: TRAY ELITE PREMIUM BICEPS TENODESIS SYS
• 03596010607584: ELITE PASS LONG BITE WITH RATCHET
• 03596010591272: ELITE PREMIUM KNOT MANIPULATOR
• 03596010590657: ELITE PREMIUM CROCHET HOOK
• 03596010579317: TRAY ELITE HIP SYSTEM
• 03596010566591: ELITE PASS SUTURE SHUTTLE W/O RATCHET
• 03596010529602: ELITE PASS SUTURE SHUTTLE WITH RATCHET
• 23596010512295: SUTURE NEEDLE SHUTTLE STERILE