Polypectomy Snare, Hexagonal - Flexible Polypectomy Snare, Large Hexagonal - Hot - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Flexible Polypectomy Snare, Large Hexagonal - Hot

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More Product Details

Catalog Number

SGH-1622L

Brand Name

Polypectomy Snare, Hexagonal

Version/Model Number

SGH-1622L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

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

5e0989dd-3f1e-4c9d-82c0-fc685a91ffb6

Public Version Date

November 05, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10816207020614

Quantity per Package

10

Contains DI Package

00816207020617

Package Discontinue Date

November 04, 2019

Package Status

Not 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