FDA.reportPublic FDA data

SpermFilter Ready-to-use gradient 80% USA

Primary DI
08719747531792
Brand
SpermFilter Ready-to-use gradient 80% USA
Company
Gynotec.B.V.
Model
SPF80-USA-0010
Device description
SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for semen preparation. The SpermFilter® Ready-to-use system can be used for semen preparation for Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF) and IntraCytoplasmatic Sperm Injection (ICSI).
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
MQLMedia, Reproductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053494000OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZEFertipro NV2006-03-23MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719747531808PackageGS15In Commercial Distribution
08719747531792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719747531808087197475318088719747531808
08719747531792087197475317928719747531792

GMDN Terms#

Term, Definition table
TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
489854382
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719747531587SpermCryo All-round USASPCA-USA-00052026-01-19
08719747531600SpermCryo All-round USASPCA-USA-00102026-01-19
08719747531631SpermFilter Ready-to-use gradient 45% USASPF45-USA-01002026-01-19
08719747531655SpermFilter Ready-to-use gradient 45% USASPF45-USA-02502026-01-19
08719747531679SpermFilter Ready-to-use gradient 80% USASPF80-USA-01002026-01-19
08719747531693SpermFilter Ready-to-use gradient 80% USASPF80-USA-02502026-01-19
08719747531778SpermFilter Ready-to-use gradient 45% USASPF45-USA-00502026-01-19
08719747531815SpermFilter Ready-to-use gradient 80% USASPF80-USA-00502026-01-19
08719747531853SpermFilter Stock Solution 100% USASPF100-USA-00502026-01-19
08719747531877SpermFilter Stock Solution 100% USASPF100-USA-01002026-01-19
08719747531891SpermFilter Stock Solution 100% USASPF100-USA-02502026-01-19
08719747531594SpermCryo All-round USASPCA-USA-00052026-01-19
08719747531617SpermCryo All-round USASPCA-USA-00102026-01-19
08719747531648SpermFilter Ready-to-use gradient 45% USASPF45-USA-01002026-01-19
08719747531662SpermFilter Ready-to-use gradient 45% USASPF45-USA-02502026-01-19
08719747531686SpermFilter Ready-to-use gradient 80% USASPF80-USA-01002026-01-19
08719747531709SpermFilter Ready-to-use gradient 80% USASPF80-USA-02502026-01-19
08719747531754SpermFilter Ready-to-use gradient 45% USASPF45-USA-00102026-01-19
08719747531785SpermFilter Ready-to-use gradient 45% USASPF45-USA-00502026-01-19
08719747531808SpermFilter Ready-to-use gradient 80% USASPF80-USA-00102026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937028508LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
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00888937028539LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028546LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028614LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028621LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028638LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028645LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028652LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028669LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028676LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028683LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028690LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028706LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028713LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028935LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028942LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029017LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029024LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029031LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029130LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029147LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029154LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029161LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029178LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029185LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751648Vitrification Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751655Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03