SMARTSTITCH OM-8000

GUDID 00817470001679

SMARTSTITCH SUTURE DEVICE HANDLE

Smith & Nephew, Inc.

Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable

• Primary Device ID: 00817470001679
• NIH Device Record Key: 3176bb1b-954e-45e6-b49e-d129d7314b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSTITCH
• Version Model Number: OM-8000
• Catalog Number: OM-8000
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470001679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123268

FDA Product Code

• NBH: ACCESSORIES,ARTHROSCOPIC

Sterilization

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

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

[00817470001679]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-11-13

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