Sil-Select Plus Lower Layer - Sil-Select Plus Lower Layer - SIP100LO (100 ml) - Fertipro NV

Duns Number:373904101

Device Description: Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution of silane-c Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)

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More Product Details

Catalog Number

-

Brand Name

Sil-Select Plus Lower Layer

Version/Model Number

SIP100LO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2018

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

-

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

f3fd776d-7693-41e7-9185-a77d187a8011

Public Version Date

May 03, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FERTIPRO NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 34