ezSnare Polypectomy Snare - Endoscopic Polypectomy Snare, Small Oval - Hot - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Endoscopic Polypectomy Snare, Small Oval - Hot

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More Product Details

Catalog Number

ET1804

Brand Name

ezSnare Polypectomy Snare

Version/Model Number

ET1804

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"

Yes

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

-

Product Code Details

Product Code

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Record Status

Public Device Record Key

51a77acd-b9c9-4855-8172-59ec4ef9bc43

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

10816207021611

Quantity per Package

10

Contains DI Package

00816207021614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"ENDO-THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 85