Endo Grasp - Grasper - Covidien LP

Duns Number:058614483

Device Description: Grasper

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More Product Details

Catalog Number

-

Brand Name

Endo Grasp

Version/Model Number

173030

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

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

K903205,K903205

Product Code Details

Product Code

HDA

Product Code Name

Forceps, obstetrical

Device Record Status

Public Device Record Key

26d1900e-e277-4195-9cd9-7eb375e8d855

Public Version Date

August 22, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884523000754

Quantity per Package

6

Contains DI Package

10884523000757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40