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 ID	09352307000346
NIH Device Record Key	371e5c6f-6cbc-43a9-b68b-4fcc7077552c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Evoke® External Closed-Loop Stimulator (eCLS)
Version Model Number	3036
Catalog Number	3036
Company DUNS	744596461
Company Name	SALUDA MEDICAL PTY LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
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

Operating and Storage Conditions

Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352307000346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P190002

FDA Product Code

LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-23
Device Publish Date	2022-03-15

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 cm	2023-10-18
09352307001633 - Evoke® CAP12 Percutaneous Lead Kit - 90 cm	2023-10-18
09352307001640 - Evoke® CAP12 Percutaneous Lead Kit - 60 cm	2023-10-18
09352307001657 - Evoke® CAP12 Percutaneous Lead Kit - 90 cm	2023-10-18
09352307001671 - Evoke® CAP12X Lead Extension Kit - 55 cm	2023-10-18
09352307001695 - Evoke® Spares Kit	2023-10-18

Trademark Results [Evoke]

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