Aquamantys

GUDID 00850043377009

Aquamantys 6.0 Bipolar Sealer (Reprocessed Device)

GREEN OR LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: 00850043377009
• NIH Device Record Key: fa6c5c1d-9a72-429b-8b6e-79f5114e9c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquamantys
• Version Model Number: GR-23-112-1
• Company DUNS: 123227484
• Company Name: GREEN OR 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043377009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211203

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: 2024-05-24
• Device Publish Date: 2024-05-16

On-Brand Devices [Aquamantys]

• 00850043377108: Aquamantys 2.3 Bipolar Sealer - Stryker (Reprocessed Device)
• 00850043377092: Aquamantys 6.0 Bipolar Sealer - Stryker (Reprocessed Device)
• 00850043377085: Aquamantys 9.5 XL Bipolar Sealer - Stryker (Reprocessed Device)
• 00850043377023: Aquamantys 9.5 XL Bipolar Sealer (Reprocessed Device)
• 00850043377016: Aquamantys 2.3 Bipolar Sealer (Reprocessed Device)
• 00850043377009: Aquamantys 6.0 Bipolar Sealer (Reprocessed Device)