SoBe® 1510-02S

GUDID 00850013858095

Red SoBe® Jointed Cutter Package (Contains 1 each of 00850013858019, 00850013858033, 00850013858118)

Stanley Medical Designs, Incorporated

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• Primary Device ID: 00850013858095
• NIH Device Record Key: 710d8adf-5eb7-48c5-a4bb-f7c955ea8d22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoBe®
• Version Model Number: 1510-02S
• Catalog Number: 1510-02S
• Company DUNS: 087844537
• Company Name: Stanley Medical Designs, Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com
• Phone: (305)-758-0211
• Email: info@stanleymedicaldesigns.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013858095 [Primary]

FDA Product Code

• FZT: Cutter, Surgical

Sterilization

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

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

[00850013858095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [SoBe®]

• 00850013858026: Blue SoBe® Jointed Cutter Assembly
• 00850013858019: Red SoBe® Jointed Cutter Assembly
• 00850013858101: Blue SoBe® Jointed Cutter Package (Contains 1 each of 00850013858026, 00850013858033, 00850013
• 00850013858095: Red SoBe® Jointed Cutter Package (Contains 1 each of 00850013858019, 00850013858033, 008500138