Endoplus - 10mm Angled Circle Grasper, Standard Handle, With - Endoplus

Duns Number:794679167

Device Description: 10mm Angled Circle Grasper, Standard Handle, With Rotation

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More Product Details

Catalog Number

-

Brand Name

Endoplus

Version/Model Number

E402SR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Device Record Status

Public Device Record Key

354d57f9-e8a9-48f4-82ff-b61491a0bcce

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDOPLUS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 839