FMwand FM2101

GUDID 20859729006053

FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop

DOMAIN SURGICAL, INC.

Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use

• Primary Device ID: 20859729006053
• NIH Device Record Key: 4b268ada-09bb-4971-8370-cb8efbfe523d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMwand
• Version Model Number: 2101
• Catalog Number: FM2101
• Company DUNS: 963249342
• Company Name: DOMAIN 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: true
• 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	00859729006059 [Primary]
GS1	10859729006056 [Package]; Contains: 00859729006059; Package: Sterile Pouch [1 Units]; In Commercial Distribution
GS1	20859729006053 [Package]; Contains: 10859729006056; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130606

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-08

On-Brand Devices [FMwand]

• 20859729006176: FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Blade
• 20859729006145: FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 5 mm Resecting Loop
• 20859729006138: FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop
• 20859729006121: FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade
• 20859729006114: FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 5 mm Resecting Loop
• 20859729006107: FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Loop
• 20859729006091: FMwand Handpiece - 150 mm Length with 5 mm Resecting Loop
• 20859729006084: FMwand Handpiece - 150 mm Length with 2 mm Dissecting Loop
• 20859729006077: FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop
• 20859729006060: FMwand Handpiece - 100 mm Length with 5 mm Resecting Loop
• 20859729006053: FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop