Aquamantys

GUDID 00643169868243

BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO

MEDTRONIC, INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00643169868243
• NIH Device Record Key: 68270bf6-18a4-407b-8d27-a464989f63f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquamantys
• Version Model Number: 23-312-1
• Company DUNS: 030200852
• Company Name: MEDTRONIC, 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: false
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169868243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132974

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: 2017-07-31

On-Brand Devices [Aquamantys]

• 00643169868274: BIPO SEALR 23-320-1 AQM ENDO VS8.7R VATS
• 00643169868267: BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7
• 00643169868243: BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO
• 00643169868236: BIPO SEALER 23-312-1 AQM SBS 5.0
• 00643169868229: BIPO SEAL 23-314-1 AQM MIN EVS3.4 NEURO
• 00643169868212: BIPO SEAL 23-314-1 AQM MIN EVS3.4
• 00643169868199: BIPOLAR SEALER 23-121-1 AQM EVS NEURO
• 00643169868182: BIPOLAR SEALER 23-113-1 AQM 2.3 OM NEURO
• 00643169868175: BIPOLAR SEALER 23-113-1 AQM 2.3
• 00643169860988: GENERATOR 40-402-1 AQM 115V
• 00643169859715: GENERATOR 40-402-1R REFURB AQM 115V