Evoke® Epidural Needle 6.5" 3014

GUDID 09352307000155

SALUDA MEDICAL PTY LIMITED

Epidural needle, non-threaded
Primary Device ID09352307000155
NIH Device Record Key0ca0a7b8-dedc-46db-805a-f8092e597a1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvoke® Epidural Needle 6.5"
Version Model Number3014
Catalog Number3014
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch
Length6.5 Inch

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
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
GS109352307000155 [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 Date2022-03-23
Device Publish Date2022-03-15

Devices Manufactured by SALUDA MEDICAL PTY LIMITED

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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

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

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