FDA.reportPublic FDA data

GM501 Gradient 45%

Primary DI
00858604006139
Brand
GM501 Gradient 45%
Company
HAMILTON THORNE, INC.
Model
4GM501GR-45-100
Device description
GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
Published
2021-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00858604006139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858604006139008586040061398586040061390858604006139

GMDN Terms#

Term, Definition table
TermDefinition
Cell centrifugation/density gradient separation reagent IVDA substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
152161337
Device count
1
HCT/P
true
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
00858604006061Intelligent ICSI MicropipetteIC.3.90.xx.B2024-12-11
00858604006054LYKOS DTSLYKOS DTS2023-06-07
00858604006276ZILOS-tk™ZILOS-tk2019-11-30
00858604006290LYKOS™LYKOS2019-11-30
00858604006108IVOSIVOS2019-11-30
00858604006719CEROSCEROS2019-11-30
00858604006016accu-beads®accu-beads®2022-03-30
00858604006115GM501 Gradient 45%4GM501GR-45-102021-04-30
00858604006122GM501 Gradient 45%4GM501GR-45-502021-04-30
00858604006221GM501 Gradient 100%4GM501G-100-1002021-04-30
00858604006238GM501 Gradient 100%4GM501G-100-2502021-04-30
00858604006245GM501 Gradient 100%4GM501G-100-5002021-04-30
00858604006146GM501 Gradient 45%4GM501GR-45-2502021-04-30
00858604006177GM501 Gradient 90%4GM501GR-90-102021-04-30
00858604006184GM501 Gradient 90%4GM501GR-90-502021-04-30
00858604006191GM501 Gradient 90%4GM501GR-90-1002021-04-30
00858604006207GM501 Gradient 90%4GM501GR-90-2502021-04-30
00858604006214GM501 Gradient 100%4GM501G-100-502021-04-30
00858604006351Intelligent ICSI MicropipetteIC.4.70.xx.C2020-02-19
00858604006320Intelligent ICSI MicropipetteIC.3.45.xx.A2019-11-20

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