Olsen Medical 80301-

GUDID 00841785113352

OLSEN MEDICAL, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841785113352
• NIH Device Record Key: 21000a91-b6de-493f-802d-8f51ac5dc999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olsen Medical
• Version Model Number: 80301-
• Catalog Number: 80301-
• Company DUNS: 079344210
• Company Name: OLSEN MEDICAL, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841785113352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130669

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

[00841785113352]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-27

On-Brand Devices [Olsen Medical]

• 00841785113352: 80301-
• 00841785112560: 42200-