Nidacon - The product is intended to be used as an - Nidacon International AB

Duns Number:631825841

Device Description: The product is intended to be used as an accessory for the separation and purification of The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation ofhuman semen samples, where the prepared sperm are used for IntraUterine Insemination (IUI) and for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies

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More Product Details

Catalog Number

PSW-100

Brand Name

Nidacon

Version/Model Number

PureSperm® Wash

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

-

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

K002630

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

37195e63-8652-44c8-bd8e-32636ba559db

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDACON INTERNATIONAL AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 19