AccessGUDID - DEVICE: Axium™ (05415067025548)

GUDID

Device Identifier (DI) Information

Brand Name: Axium™
Version or Model: MN10450-90A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MN10450-90A
Company Name: SPINAL MODULATION, INC.

Primary DI Number: 05415067025548
Issuing Agency: GS1
Commercial Distribution End Date: April 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 617312272 *Terms of Use

Device Description: 90cm SlimTip Implant Lead Kit

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?
62423	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection	An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PMP	Dorsal root ganglion stimulator for pain relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150004	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
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Centimeter

Device Record Status

Public Device Record Key: 49126fe8-5825-4e18-87e9-3be6c218a8da
Public Version Date: August 15, 2023
Public Version Number: 4
DI Record Publish Date: March 29, 2016