Evoke® CAP12 Percutaneous Lead Kit - 90 cm 3009

GUDID 09352307001596

SALUDA MEDICAL PTY LIMITED

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Primary Device ID09352307001596
NIH Device Record Key5a56af1c-62e8-403d-8d53-8a5cfe9ce4c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvoke® CAP12 Percutaneous Lead Kit - 90 cm
Version Model Number3009
Catalog Number3009
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

Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS109352307001596 [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

On-Brand Devices [Evoke® CAP12 Percutaneous Lead Kit - 90 cm]

093523070015963009
093523070007803009
093523070016573009
093523070016333009

Trademark Results [Evoke]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVOKE
EVOKE
98644624 not registered Live/Pending
Evoke Design & Creative, LLC
2024-07-11
EVOKE
EVOKE
98465988 not registered Live/Pending
Evoke Tattoos LLC
2024-03-25
EVOKE
EVOKE
98438597 not registered Live/Pending
TDJ Buyer, LLC
2024-03-07
EVOKE
EVOKE
98429583 not registered Live/Pending
BRAZILIAN LAB EXPORTADORA E IMPORTADORALTDA
2024-03-01
EVOKE
EVOKE
98421224 not registered Live/Pending
West Shore Home, LLC
2024-02-26
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

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