FDA.reportPublic FDA data

RI MSC

Primary DI
05060170180181
Brand
RI MSC
Company
RESEARCH INSTRUMENTS LIMITED
Model
Migration Sedimenation Chamber
Catalog number
7-74-501/20
Device description
Assisted Reproduction Labware
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K112413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112413000RI MSC (MIGRATION SEDIMENTATION CHAMBER)Research Instruments , Ltd.2012-07-13MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060170180181PrimaryGS10
05060170183434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060170180181050601701801815060170180181
05060170183434050601701834345060170183434

GMDN Terms#

Term, Definition table
TermDefinition
Sperm filtration systemAn assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from direct sunlight (UV)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4546790202origio@origio.com

Regulatory Flags#

DUNS number
536139413
Device count
20
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060170181454EZ-Tip125 micron tip id7-72-2125/52017-12-22
05060170181461EZ-Tip135 micron tip id7-72-2135/52017-12-22
05060170181478EZ-Tip145 micron tip id7-72-2145/52017-12-22
05060170181485EZ-Tip155 micron tip id7-72-2155/52017-12-22
05060170181492EZ-Tip170 micron tip id7-72-2170/52017-12-22
05060170181508EZ-Tip200 micron tip id7-72-2200/52017-12-22
05060170181515EZ-Tip290 micron tip id7-72-2290/52017-12-22
05060170181522EZ-Tip600 micron tip id7-72-2600/52017-12-22
05060170181539EZ-Tip125 micron tip id7-72-4125/202017-12-22
05060170181546EZ-Tip135 micron tip id7-72-4135/202017-12-22
05060170181553EZ-Tip145 micron tip id7-72-4145/202017-12-22
05060170181560EZ-Tip155 micron tip id7-72-4155/202017-12-22
05060170181577EZ-Tip170 micron tip id7-72-4170/202017-12-22
05060170181591EZ-Tip200 micron tip id7-72-4200/202017-12-22
05060170181607EZ-Tip290 micron tip id7-72-4290/202017-12-22
05060170181614EZ-Tip600 micron tip id7-72-4600/202017-12-22
05060170181690EZ-GripEZ-Grip7-72-28002017-12-22
05060170183328EZ-Tip75 micron tip id7-72-2075/52017-12-22
05060170183380EZ-GripEZ-Grip with Comfort Rest7-72-28022017-12-22
05060170183441EZ-Tip75 micron tip id7-72-4075/202017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00888937027952ZyMotCoopersurgical, 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
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02