AccessGUDID - DEVICE: Axium™ (05415067025562)

GUDID

Device Identifier (DI) Information

Brand Name: Axium™
Version or Model: MN10550-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MN10550-50
Company Name: SPINAL MODULATION, INC.

Primary DI Number: 05415067025562
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: 50cm Lead Extension 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?
65308	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension	An implantable device intended to extend the electrical connection between a spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator and a lead(s). It typically includes small connectors to enable attachment to the lead(s) and pulse generator, and a length of insulated wire; the lead(s) and pulse generator are not included.	Active	false

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

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Centimeter

Device Record Status

Public Device Record Key: 1d051251-e1c2-4b3b-801a-6df1d6ad538e
Public Version Date: August 15, 2023
Public Version Number: 4
DI Record Publish Date: March 29, 2016