SPEEDSTITCH OM-7000

GUDID 00817470001402

SPEEDSTITCH DEVICE

Smith & Nephew, Inc.

Suturing unit, reusable

• Primary Device ID: 00817470001402
• NIH Device Record Key: 9de865fb-f008-4a74-8b23-888ec3268650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDSTITCH
• Version Model Number: OM-7000
• Catalog Number: OM-7000
• 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
• 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	00817470001402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042031

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

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

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

Moist Heat or Steam Sterilization

[00817470001402]

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

On-Brand Devices [SPEEDSTITCH]

• 00817470005929: SPEEDSTITCH NEEDLE
• 00817470001402: SPEEDSTITCH DEVICE