FDA.reportPublic FDA data

ZyMot

Primary DI
00888937027952
Brand
ZyMot
Company
Coopersurgical, Inc.
Model
Multi 3mL
Catalog number
ZMH3000M
Device description
Sperm Separation Device
Published
2026-01-23
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
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173075000ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.2018-03-08MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937027952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937027952008889370279528889370279520888937027952

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027495Endoscopic Seals26153EAU-102026-10-22
00888937027501Endoscopic Seals27550ZAG-102026-10-22
00888937027556Endoscopic SealsC0100132026-10-22
00888937027563Endoscopic SealsC0100142026-10-22
00888937027327ER-SpecC0203002026-08-05
00888937027945ZyMotMulti 850 microLZMH0850M2026-01-23
05060488047336EZ-GripDenudation and Handling Pipettor7-72-28002025-04-11
05060488047343EZ-GripWith Comfort Rest Denudation and Handling Pipettor7-72-28022025-04-11
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843277100093SwimCount® HarvesterMotilitycount ApSMQK2026-07-07
00843277100109SwimCount® HarvesterMotilitycount ApSMQK2026-07-07
00888937029048LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029055LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029062LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
B056CLRCTLG1CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG1S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTLG2CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTPK1CRYOLOCK(PK)BIOTECH INCORPORATEDMQK2025-10-27
B056CLRCTPR1CRYOLOCK(PR)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPK1S-CRYOLOCK (PK)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPR1S-CRYOLOCK (PR)BIOTECH INCORPORATEDMQK2025-10-27
20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
06975183900017Hariomed culture dishHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900208Hariomed humidification boxHua Yue Medical Technology Co., Ltd.MQK2025-09-30
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02