FDA.reportPublic FDA data

SpermFilter Ready-to-use gradient 80% USA

Primary DI
08719747531709
Brand
SpermFilter Ready-to-use gradient 80% USA
Company
Gynotec.B.V.
Model
SPF80-USA-0250
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
OTC
false
Sterile
true
Single use
false

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
08719747531709PackageGS11In Commercial Distribution
08719747531693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719747531709087197475317098719747531709
08719747531693087197475316938719747531693

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 Volume250Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
489854382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08719747531792SpermFilter Ready-to-use gradient 80% USASPF80-USA-00102026-01-19
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
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
00888937028515LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028522LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
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