Aquamantys

GUDID 00810041638212

Provision

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: 00810041638212
• NIH Device Record Key: 0c1f9e6b-a292-4617-951d-72f1e1067c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquamantys
• Version Model Number: 23-121-1
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00810041638212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172647

FDA Product Code

• NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [Aquamantys]

• B504CB2331410: 23-314-1
• B504CB2312110: 23-121-1
• B504CB2311310: 23-113-1
• B504CB2311210: 23-112-1
• 00810041638229: 23-314-1
• 00810041638212: 23-121-1
• 00810041638205: 23-113-1
• 00810041638199: 23-112-1