AccessGUDID - DEVICE: Axium™ (05415067025494)

GUDID

Device Identifier (DI) Information

Brand Name: Axium™
Version or Model: MN10100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MN10100
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067025494
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Trial Neurostimulator

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:	No
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?
61472	Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator	An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).	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
P150004	005

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 14 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fcfbef7d-0c0f-4fb6-aefc-257afa980697
Public Version Date: August 01, 2023
Public Version Number: 4
DI Record Publish Date: March 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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