Aquamantys ®

GUDID 00643169456211

BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO

MEDTRONIC, INC.

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

• Primary Device ID: 00643169456211
• NIH Device Record Key: 199d83cf-f6f8-4447-83f9-f179744bd0da
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169456211 [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: 2016-06-12

On-Brand Devices [Aquamantys ®]

• 00643169078673: BIPOLAR SEALER 23-314-1 AQM MINI EVS 3.4
• 00643169078666: BIPOLAR SEALER 23-313-1 AQM 9.5XL
• 00643169078659: BIPOLAR SEALER 23-312-1 AQM SBS 5.0
• 00643169078611: BIPOLAR SEALER 23-301-1 AQM MBS W/LIGHT
• 00643169078604: BIPOLAR SEALER 23-121-1 AQM EVS
• 00643169078598: BIPOLAR SEALER 23-113-1 AQM 2.3
• 00643169078581: BIPOLAR SEALER 23-112-1 AQM 6.0
• 00643169532205: BIPOLAR SEALER 23-113-1 AQM 2.3 OM NEURO
• 00643169526228: BIPO SEALR 23-320-1 AQM ENDO VS8.7R VATS
• 00643169456228: BIPO SEAL 23-314-1 AQM MIN EVS3.4 NEURO
• 00643169456211: BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO
• 00643169456204: BIPOLAR SEALER 23-121-1 AQM EVS NEURO
• 00643169181748: BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7