Single Use Electrosurgical Snare SD-400 - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

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More Product Details

Catalog Number

-

Brand Name

Single Use Electrosurgical Snare SD-400

Version/Model Number

SD-400-15

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2022

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

FDI

Product Code Name

SNARE, FLEXIBLE

Device Record Status

Public Device Record Key

60568d69-a004-4775-8da6-7168074fc1ba

Public Version Date

August 22, 2022

Public Version Number

6

DI Record Publish Date

December 13, 2017

Additional Identifiers

Package DI Number

14953170396714

Quantity per Package

10

Contains DI Package

04953170396717

Package Discontinue Date

August 19, 2022

Package Status

Not 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