AccessGUDID - DEVICE: NICO BrainPath (00816744028459)

GUDID

Device Identifier (DI) Information

Brand Name: NICO BrainPath
Version or Model: NN-8045
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NICO CORPORATION

Primary DI Number: 00816744028459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829838288 *Terms of Use

Device Description: Navigation Probe Adapter

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?
65748	Neurosurgical retraction obturator/probe adaptor	A manual device intended to connect a neurosurgical retraction obturator to a probe (e.g., stereotactic/electromagnetic surgery system probe), typically of incompatible sizes. It typically incorporates a male rod-like attachment intended to fit into the lumen of the obturator, and a female attachment intended to accept the probe; the obturator and probe are not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZT	Retractor, Self-Retaining, For Neurosurgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e1a193b-5c91-4523-8c93-7c2c36ef8fa3
Public Version Date: November 14, 2024
Public Version Number: 4
DI Record Publish Date: April 15, 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
10816744038455	2	00816744028459		In Commercial Distribution

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 317-660-7118
Email: info@NICOneuro.com

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