AccessGUDID - DEVICE: MindsEye Expandable Port (00860003476819)

GUDID

Device Identifier (DI) Information

Brand Name: MindsEye Expandable Port
Version or Model: 6.2cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N-EXP1A-062
Company Name: Minnetronix Neuro, Inc.

Primary DI Number: 00860003476819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117223608 *Terms of Use

Device Description: subcortical access sheath 6.2 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:	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?
62990	Neurosurgical retraction cannula	A single-lumen surgical device designed to be used with an obturator to atraumatically displace brain tissues without tissue penetration (e.g., careful insertion between gyri) to create a surgical access corridor to a specific lesion/abnormality within the brain; a disposable obturator may be included. It is made of polymer materials and may include depth markings. 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 [?]
K202072	000

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 -29 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 6.2 Centimeter

Device Record Status

Public Device Record Key: ff4274a0-94eb-4dcb-9ba0-76ba35d33d61
Public Version Date: August 05, 2024
Public Version Number: 5
DI Record Publish Date: April 18, 2022