PERCUVANCE - 5 MILLIMETER Spatula Cautery Tip - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 5 MILLIMETER Spatula Cautery Tip

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More Product Details

Catalog Number

PCVSPT5

Brand Name

PERCUVANCE

Version/Model Number

IPN914236

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2021

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

K181852,K181852,K181852,K181852

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

420a5c46-3873-4dcc-8fe8-08ce80fe4786

Public Version Date

June 16, 2021

Public Version Number

8

DI Record Publish Date

October 22, 2018

Additional Identifiers

Package DI Number

44026704640254

Quantity per Package

6

Contains DI Package

34026704640257

Package Discontinue Date

June 15, 2021

Package Status

Not 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