AccessGUDID - DEVICE: Nalu Medical, Inc. (00812537036175)

GUDID

Device Identifier (DI) Information

Brand Name: Nalu Medical, Inc.
Version or Model: 72013-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72013-US
Company Name: NALU MEDICAL, INC.

Primary DI Number: 00812537036175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067140761 *Terms of Use

Device Description: Trial Lead Kit (4 contact, 40 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?
65533	Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system lead	An invasive, electrically-insulated wire with a distal electrode intended to be introduced into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for percutaneous wired transmission of electrical impulses from an external pulse generator, to the target nerves, for analgesia during a trial period (<= 30 days). It is designed to validate therapy/test operating parameters prior to introduction of a permanent implantable analgesic electrical stimulation system.	Active	false

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
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: 40 Centimeter

Device Record Status

Public Device Record Key: a527da5d-58d5-4d92-9c04-419b530ceeee
Public Version Date: August 02, 2021
Public Version Number: 1
DI Record Publish Date: July 23, 2021

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: 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

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