WECK - NON-STERILE DISPOSABLE BIPOLAR CORDS 50 PER BOX - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: NON-STERILE DISPOSABLE BIPOLAR CORDS 50 PER BOX

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More Product Details

Catalog Number

394249

Brand Name

WECK

Version/Model Number

IPN039267

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

K771752,K771752,K771752

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

06c257ac-ce86-4d83-ae59-c43bee3ddffb

Public Version Date

October 29, 2020

Public Version Number

2

DI Record Publish Date

June 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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