KISSES Internal Fixture - Kisses Internal Fixture Φ4.2/L9.5 - Achimhai Medical Corporation

Duns Number:694197900

Device Description: Kisses Internal Fixture Φ4.2/L9.5

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More Product Details

Catalog Number

KS4210SA-A

Brand Name

KISSES Internal Fixture

Version/Model Number

KS4210SA

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142813

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

3a21f0c5-8935-49b9-a54c-72295d8a13c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACHIMHAI MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 1228