Buffalo Filter - Laser & Electrosurgery In-Line Filter - Buffalo Filter

Duns Number:787855907

Device Description: Laser & Electrosurgery In-Line Filter

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More Product Details

Catalog Number

-

Brand Name

Buffalo Filter

Version/Model Number

BILF101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 18, 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

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Device Record Status

Public Device Record Key

d0199345-a310-459c-8778-a9fbbc8a0033

Public Version Date

January 21, 2019

Public Version Number

3

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

10851136002669

Quantity per Package

10

Contains DI Package

00851136002662

Package Discontinue Date

January 18, 2019

Package Status

Not in Commercial Distribution

Package Type

case

"BUFFALO FILTER" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 104