OPTIMIZER - OPTIMIZER Polypectomy Snare; X-Small Oval Loop, - Conmed Corporation

Duns Number:071595540

Device Description: OPTIMIZER Polypectomy Snare; X-Small Oval Loop, Firm Wire, Olympus Connector

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More Product Details

Catalog Number

000478

Brand Name

OPTIMIZER

Version/Model Number

000478

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

53064c22-183d-4970-8bd6-99339d1770f4

Public Version Date

April 12, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20653405053429

Quantity per Package

10

Contains DI Package

10653405053422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95