NA - Smoke Evacuation Pre-filter - COASTAL LIFE TECHNOLOGIES, INC.

Duns Number:809254670

Device Description: Smoke Evacuation Pre-filter

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

6081K

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)

-

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

c543900d-b695-4ec1-a060-51f39e857c28

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20814716020788

Quantity per Package

6

Contains DI Package

10814716020781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COASTAL LIFE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 41