Evoke ® CAP12 Percutaneous Lead Kit - 60 cm 3008

GUDID 09352307001589

SALUDA MEDICAL PTY LIMITED

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Primary Device ID09352307001589
NIH Device Record Key175f4a14-36d4-4f23-b553-960ea803c465
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvoke ® CAP12 Percutaneous Lead Kit - 60 cm
Version Model Number3008
Catalog Number3008
Company DUNS744596461
Company NameSALUDA MEDICAL PTY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109352307001589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

Devices Manufactured by SALUDA MEDICAL PTY LIMITED

09352307001565 - Evoke® Closed-Loop Stimulator (CLS)2023-10-18
09352307001572 - Evoke® Closed-Loop Stimulator (CLS)2023-10-18
09352307001626 - Evoke® CAP12 Percutaneous Lead Kit - 60 cm2023-10-18
09352307001633 - Evoke® CAP12 Percutaneous Lead Kit - 90 cm2023-10-18
09352307001640 - Evoke® CAP12 Percutaneous Lead Kit - 60 cm2023-10-18
09352307001657 - Evoke® CAP12 Percutaneous Lead Kit - 90 cm2023-10-18
09352307001671 - Evoke® CAP12X Lead Extension Kit - 55 cm2023-10-18
09352307001695 - Evoke® Spares Kit 2023-10-18

Trademark Results [Evoke]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVOKE
EVOKE
98274527 not registered Live/Pending
DAZIAN, LLC
2023-11-16
EVOKE
EVOKE
97866466 not registered Live/Pending
Comtech Telecommunications Corp.
2023-03-31
EVOKE
EVOKE
97765483 not registered Live/Pending
Pinnacle Transplant Technologies, LLC
2023-01-24
EVOKE
EVOKE
97680174 not registered Live/Pending
Columbia Vehicle Group, Inc.
2022-11-16
EVOKE
EVOKE
97661957 not registered Live/Pending
EVOKE SYSTEMS, LLC
2022-11-03
EVOKE
EVOKE
97626227 not registered Live/Pending
West118 Investments, LLC
2022-10-10
EVOKE
EVOKE
97620796 not registered Live/Pending
West118 Investments, LLC
2022-10-05
EVOKE
EVOKE
97525775 not registered Live/Pending
Triangle Tube Phase III Co.
2022-07-29
EVOKE
EVOKE
97502681 not registered Live/Pending
Cesar de Campos, Paulo
2022-07-14
EVOKE
EVOKE
97362071 not registered Live/Pending
EVoke Systems, LLC
2022-04-13
EVOKE
EVOKE
90806394 not registered Live/Pending
Fleetwood Group, Inc.
2021-07-01
EVOKE
EVOKE
90571378 not registered Live/Pending
Evoke Nutrition Inc.
2021-03-10

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