Catalog Number

7900-1000-02

Brand Name

ENDOSKELETON TL RETRACTOR

Version/Model Number

7900-1000-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2020

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

K063729

Product Code

GXZ

Product Code Name

ELECTRODE, NEEDLE

Public Device Record Key

3673abcb-482b-4477-bf3f-cdda7c4c708d

Public Version Date

June 14, 2021

Public Version Number

6

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-