ROBI 38810ON

GUDID 04048551325179

RoBi® Forceps Insert with Outer Sheath

Karl Storz GmbH & Co. KG

Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable

• Primary Device ID: 04048551325179
• NIH Device Record Key: 8040db6b-fab7-48b8-b63f-62955e516849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROBI
• Version Model Number: 38810ON
• Catalog Number: 38810ON
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551325179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962030

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

[04048551325179]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-06-02
• Device Publish Date: 2016-09-23

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• 04048551325186: RoBi® Forceps Insert with Outer Sheath
• 04048551325179: RoBi® Forceps Insert with Outer Sheath
• 04048551325162: RoBi® Forceps Insert with Outer Sheath