Sil-Select Plus Lower Layer

FDA UDI

Class II (US FDA UDI)

by Fertipro NV

Identity

Trade Name: Sil-Select Plus Lower Layer FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip FDA UDI
Model / Reference: SIP100LO_AF (100ml) FDA UDI
Description: Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip FDA UDI

Identifiers

Primary DI / UDI-DI: 54119670011634 FDA UDI
510(k) Number: K053494 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

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Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Sil-Select Plus Lower Layer by Fertipro NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K053494 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fertipro NV

Sources (1)

FDA UDI c75587bd-2360-4681-b5da-73aefa22d1e4 37 fields · synced Jun 1, 2026