Bulb For Ellik Evacuator Latex - "194-2 Bulb For Ellik Evacuator" - Gyrus Acmi, Inc.

Duns Number:007198742

Device Description: "194-2 Bulb For Ellik Evacuator"

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More Product Details

Catalog Number

-

Brand Name

Bulb For Ellik Evacuator Latex

Version/Model Number

194-2

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

KQT

Product Code Name

EVACUATOR, GASTRO-UROLOGY

Device Record Status

Public Device Record Key

84e7e9e3-e08c-49f7-9a4d-2ae42864e538

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4