Aquamantys ®

GUDID 00643169456211

BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO

MEDTRONIC, INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID00643169456211
NIH Device Record Key199d83cf-f6f8-4447-83f9-f179744bd0da
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquamantys ®
Version Model Number23-312-1
Company DUNS030200852
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169456211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-12

On-Brand Devices [Aquamantys ®]

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

Trademark Results [Aquamantys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AQUAMANTYS
AQUAMANTYS
78718381 3450948 Live/Registered
Medtronic Advanced Energy LLC
2005-09-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.