AccessGUDID - DEVICE: NICO BrainPath Approach (00816744023102)

GUDID

Device Identifier (DI) Information

Brand Name: NICO BrainPath Approach
Version or Model: NN-3010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NICO CORPORATION

Primary DI Number: 00816744023102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829838288 *Terms of Use

Device Description: BP & Illumination Pack [13.5x95 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Illum]

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:	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?
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJG	Neurological Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: efb4cbfd-c35c-49f5-b072-a96be05f11ab
Public Version Date: April 13, 2021
Public Version Number: 1
DI Record Publish Date: April 05, 2021