AccessGUDID - DEVICE: Evoke® Epidural Needle 6.5" (09352307000155)

GUDID

Device Identifier (DI) Information

Brand Name: Evoke® Epidural Needle 6.5"
Version or Model: 3014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3014
Company Name: SALUDA MEDICAL PTY LIMITED

Primary DI Number: 09352307000155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 744596461 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58293	Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 6.5 Inch

Device Record Status

Public Device Record Key: 0ca0a7b8-dedc-46db-805a-f8092e597a1b
Public Version Date: October 09, 2023
Public Version Number: 2
DI Record Publish Date: March 15, 2022