AccessGUDID - DEVICE: Nalu Medical, Inc. (00812537035758)

GUDID

Device Identifier (DI) Information

Brand Name: Nalu Medical, Inc.
Version or Model: 12003-035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12003-035
Company Name: NALU MEDICAL, INC.

Primary DI Number: 00812537035758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067140761 *Terms of Use

Device Description: Lead Extension (4 contact, 35 cm)

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:	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?
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	true

FDA Product Code

[?]

Product Code	Product Code Name
GZF	Stimulator, Peripheral Nerve, 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
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 35 Centimeter

Device Record Status

Public Device Record Key: bea82ef5-144f-4f02-9d13-bb0e181916a6
Public Version Date: July 02, 2025
Public Version Number: 4
DI Record Publish Date: June 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00812537035888	1	00812537035758		In Commercial Distribution	Box
10812537035755	5	00812537035758		In Commercial Distribution	Box

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

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES