Sonnet - Sonnet, Short Throw Polypectomy Snare - COOK IRELAND LTD

Duns Number:988559035

Device Description: Sonnet, Short Throw Polypectomy Snare

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More Product Details

Catalog Number

SSH-28-S

Brand Name

Sonnet

Version/Model Number

G34161

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

-

Product Code Details

Product Code

FDI

Product Code Name

SNARE, FLEXIBLE

Device Record Status

Public Device Record Key

39a83680-0f1a-4426-b98a-63edb2428159

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10827002341613

Quantity per Package

10

Contains DI Package

00827002341616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COOK IRELAND LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 888
3 A medical device with high risk that requires premarket approval 165