Catalog Number

N-EXP1A-062

Brand Name

MindsEye Expandable Port

Version/Model Number

6.2cm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202072

Product Code

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Public Device Record Key

ff4274a0-94eb-4dcb-9ba0-76ba35d33d61

Public Version Date

September 26, 2022

Public Version Number

3

DI Record Publish Date

April 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-