ReNew XR

GUDID 00811099013853

MICROLINE SURGICAL, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 00811099013853
• NIH Device Record Key: 37b2303c-28a5-402a-b4ac-fd7b86765b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReNew XR
• Version Model Number: 3533
• Company DUNS: 184080570
• Company Name: MICROLINE SURGICAL, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811099013853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201884

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

[00811099013853]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [ReNew XR]

• 00811099013853: 3533
• 00811099013846: 3532
• 00811099013839: 3531
• 00811099013822: 3530