ReNew XR Handpiece with Reference Length Markings

GUDID 00811099014287

MICROLINE SURGICAL, INC.

Electrosurgical handpiece, reusable

• Primary Device ID: 00811099014287
• NIH Device Record Key: 3bc1bcf0-2bb0-456f-b968-67e71bf8455f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReNew XR Handpiece with Reference Length Markings
• Version Model Number: 3946M
• 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	00811099014287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234147

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

[00811099014287]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-03

On-Brand Devices [ReNew XR Handpiece with Reference Length Markings]

• 00811099014300: 3945M
• 00811099014287: 3946M
• 00811099014270: 3942M
• 00811099014263: 3941M
• 00811099014256: 3943M
• 00081109901429: 3944M
• 00811099014294: 3944M