Fertipro NV

Address:INDUSTRIE PARK NOORD 32,BEERNEM West-Vlaanderen,BE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Media, Reproductive (MQL) (10)

Premarket Exempt

Yes No

Clear

Sil-Select Plus Upper Layer - 54119670010644 Catalog Number :

Device Description : Sil-Select Plus Upper Layer - SIP025UP (2.5 ml) Sil-Select Plus™ is a solution o Sil-Select Plus Upper Layer - SIP025UP (2.5 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Lower Layer - 54119670010712 Catalog Number :

Device Description : Sil-Select Plus Lower Layer - SIP042LO (4,2ml) Sil-Select Plus™ is a solution of Sil-Select Plus Lower Layer - SIP042LO (4,2ml) 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Lower Layer - 54119670010880 Catalog Number :

Device Description : Sil-Select Plus Lower Layer - SIP050LO (50 ml) Sil-Select Plus™ is a solution of Sil-Select Plus Lower Layer - SIP050LO (50 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Upper Layer - 54119670011184 Catalog Number :

Device Description : Sil-Select Plus Upper Layer - SIP50UP (50 ml) Sil-Select Plus™ is a solution of Sil-Select Plus Upper Layer - SIP50UP (50 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Lower Layer - 54119670011566 Catalog Number :

Device Description : Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution o 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Lower Layer - 54119670011634 Catalog Number :

Device Description : Sil-Select Plus™Sperm preparation mediaSil-Select Plus™ is our home made new and Sil-Select Plus™Sperm preparation mediaSil-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

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Upper Layer - 54119670011870 Catalog Number :

Device Description : Sil-Select Plus Upper Layer - SIP100UP (100 ml) Sil-Select Plus™ is a solution Sil-Select Plus Upper Layer - SIP100UP (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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus Upper Layer - 54119670012174 Catalog Number :

Device Description : Sil-Select Plus™ Upper Layer - SIP500UP (500ml) Sil-Select Plus™ is a solution o Sil-Select Plus™ Upper Layer - SIP500UP (500ml) 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus 80% - 54119670012242 Catalog Number :

Device Description : Sil-Select Plus™ 80% with gentamicin (SIP80_050G) (50 ml ) Sil-Select Plus™ is a Sil-Select Plus™ 80% with gentamicin (SIP80_050G) (50 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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sil-Select Plus 80% - 54119670012310 Catalog Number :

Device Description : Sil-Select Plus 80% - SIP80_100 (100 ml) Sil-Select Plus™ is a solution of silan Sil-Select Plus 80% - SIP80_100 (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)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

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