AccessGUDID - DEVICE: Nalu Medical, Inc. (00812537036021)

GUDID

Device Identifier (DI) Information

Brand Name: Nalu Medical, Inc.
Version or Model: 71021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71021
Company Name: NALU MEDICAL, INC.

Primary DI Number: 00812537036021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067140761 *Terms of Use

Device Description: Nalu Neurostimulation Kit (Ported, Dual 8, 2 cm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
64970	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable	An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.	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 14 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Centimeter

Device Record Status

Public Device Record Key: eaf9fe19-aa3b-4957-b3b3-de8801c6132b
Public Version Date: January 10, 2024
Public Version Number: 1
DI Record Publish Date: January 02, 2024

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-618-3402
Email: info@nalumed.com

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