Catalog Number

EP3480RR

Brand Name

Endo Allis Forcep, 35cm with Ratchet and Rotate Handle

Version/Model Number

EP3480RR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2018

Issuing Agency

In GS1

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

K925079

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

edaeb0ca-9ef4-48d0-9b82-94c3fc1c5fe6

Public Version Date

August 21, 2019

Public Version Number

5

DI Record Publish Date

May 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-