Evoke® External Closed-Loop Stimulator (eCLS) 3036

GUDID 09352307000346

SALUDA MEDICAL PTY LIMITED

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Primary Device ID09352307000346
NIH Device Record Key371e5c6f-6cbc-43a9-b68b-4fcc7077552c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvoke® External Closed-Loop Stimulator (eCLS)
Version Model Number3036
Catalog Number3036
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109352307000346 [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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-23
Device Publish Date2022-03-15

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
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Pinnacle Transplant Technologies, LLC
2023-01-24
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Columbia Vehicle Group, Inc.
2022-11-16
EVOKE
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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
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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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