SMARTSTITCH OM-8000

GUDID 00817470001679

SMARTSTITCH SUTURE DEVICE HANDLE

Smith & Nephew, Inc.

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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• 00885556915899 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
• 00885556915905 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
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• 00885556901960 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP
• 00885556901977 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
• 00885556901984 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP