AccessGUDID - DEVICE: Nalu Medical, Inc. (00812537036533)

GUDID

Device Identifier (DI) Information

Brand Name: Nalu Medical, Inc.
Version or Model: 23002-025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23002-025
Company Name: NALU MEDICAL, INC.

Primary DI Number: 00812537036533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067140761 *Terms of Use

Device Description: Stylet (Bent, 25 cm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
65531	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection	An implantable, 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), to transmit electrical impulses received transcutaneously from a skin surface electrode (not included) to the target nerves for the relief/treatment of acute and/or chronic intractable pain. It may include disposable devices associated with implantation and stabilization (e.g., introducer, stylet, adhesive pad).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 away from sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Centimeter

Device Record Status

Public Device Record Key: d8fcf9a5-ff1a-45a1-8cd7-3af43ba0bf67
Public Version Date: September 23, 2022
Public Version Number: 1
DI Record Publish Date: September 15, 2022