ACCURIAN™

GUDID 00763000312268

INTRODUCER AI0006 150MM 12MM ENHANCED

MEDTRONIC SOFAMOR DANEK, INC.

Radio-frequency ablation system
Primary Device ID00763000312268
NIH Device Record Keyecea05d4-70ef-44d2-bb79-e3466f9fa65e
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCURIAN™
Version Model NumberAI0006
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count10
DM Exempttrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge
Length150 Millimeter
Needle Gauge17 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000312268 [Unit of Use]
GS120763000312262 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [ACCURIAN™]

00763000312268INTRODUCER AI0006 150MM 12MM ENHANCED
00763000312251INTRODUCER AI0005 100MM 12MM ENHANCED
00763000312244INTRODUCER AI0004 50MM 12MM ENHANCED
00763000312220INTRODUCER AI0002 100MM 10MM ENHANCED
00763000312213INTRODUCER AI0001 50MM 10MM ENHANCED
00763000312237INTRODUCER AI0003 150MM 10MM ENHANCED
00763000405014SFTWR KIT AGSW001 ACCURIAN GENRTR 1.1

Trademark Results [ACCURIAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCURIAN
ACCURIAN
87959954 5771242 Live/Registered
Medtronic, Inc.
2018-06-13
ACCURIAN
ACCURIAN
78931716 3469714 Dead/Cancelled
TRS Quality, Inc.
2006-07-18
ACCURIAN
ACCURIAN
78433632 3012289 Dead/Cancelled
TRS Quality, Inc.
2004-06-11
ACCURIAN
ACCURIAN
78433498 3181576 Dead/Cancelled
TRS Quality, Inc.
2004-06-10
ACCURIAN
ACCURIAN
78308158 2999052 Dead/Cancelled
GENERAL WIRELESS IP HOLDINGS LLC
2003-10-01
ACCURIAN
ACCURIAN
78308158 2999052 Dead/Cancelled
GENERAL WIRELESS OPERATIONS INC.
2003-10-01
ACCURIAN
ACCURIAN
77298471 3426697 Dead/Cancelled
TRS Quality, Inc.
2007-10-08
ACCURIAN
ACCURIAN
77267478 not registered Dead/Abandoned
TRS Quality, Inc.
2007-08-29
ACCURIAN
ACCURIAN
77101675 not registered Dead/Abandoned
TRS Quality, Inc.
2007-02-07
ACCURIAN
ACCURIAN
77012615 3382456 Dead/Cancelled
TRS Quality, Inc.
2006-10-03

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