DISPOSABLE ELECTROSURGICAL SNARE - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

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More Product Details

Catalog Number

-

Brand Name

DISPOSABLE ELECTROSURGICAL SNARE

Version/Model Number

SD-230U-20

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

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Device Record Status

Public Device Record Key

214a22a8-6879-4936-b640-3d05fa698581

Public Version Date

December 06, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14953170142038

Quantity per Package

10

Contains DI Package

04953170142031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52