PERCUVANCE - 5MM GRIPPER GRASPER - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 5MM GRIPPER GRASPER

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More Product Details

Catalog Number

PCVGG5

Brand Name

PERCUVANCE

Version/Model Number

IPN027869

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

K153063,K153063,K153063

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

9d72e42e-1df1-4027-ae60-97d5f4837bea

Public Version Date

January 25, 2021

Public Version Number

9

DI Record Publish Date

November 16, 2017

Additional Identifiers

Package DI Number

24026704582819

Quantity per Package

6

Contains DI Package

14026704582812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26