Catalog Number

-

Brand Name

5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation

Version/Model Number

EP3460-45RR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

4694aa0b-8fc2-4b7d-a724-1cadbbcda759

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-