FDA.reportPublic FDA data

LifeGlobal® GPS® Dishware

Primary DI
00815965021829
Brand
LifeGlobal® GPS® Dishware
Company
LIFEGLOBAL GROUP, LLC
Model
4GPS-010
Catalog number
4GPS-010
Device description
Four-Well GPS Dish (1 sleeve of 10)
Published
2016-09-21
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
K080395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080395000SUNIVF DISHES<Genx> Intl., Inc.2008-08-13MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815965021829PrimaryGS10
00815965021775Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815965021829008159650218298159650218290815965021829
00815965021775008159650217758159650217750815965021775

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA sterile container intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)720-6375Sales@LifeGlobal.com

Regulatory Flags#

DUNS number
141732011
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815965020358LifeGlobal® MediaLGPS-005LGPS-0052016-09-21
00815965020693LifeGlobal® MediaGHSA-005GHSA-0052016-09-21
00815965020754LifeGlobal® MediaLPVP-002LPVP-0022016-09-21
00815965020938Coda®CIPR-001CIPR-0012016-09-21
00815965020945Coda®CXBL-001CXBL-0012016-09-21
00815965020952Coda®CXGR-001CXGR-0012016-09-21
00815965020976Coda®GCIF-001GCIF-0012016-09-21
00815965021195Coda®GCAF-001GCAF-0012016-09-21
00815965021331LifeGlobal® MicropipetMPAH-30*01*MPAH-30*01*2016-09-21
00815965021348Coda®GCAF-701GCAF-7012016-09-21
00815965021355Coda®CAFK-901CAFK-9012016-09-21
00815965021867LifeGlobal® MicropipetMPBL-35B*01*MPBL-35B*01*2016-09-23
00815965021874LifeGlobal® MicropipetMPBL-25F-30*01*MPBL-25F-30*01*2016-09-23
00815965021881LifeGlobal® MicropipetMPBL-35F-30*01*MPBL-35F-30*01*2016-09-23
00815965021898LifeGlobal® MicropipetMPBL-35F-35*01*MPBL-35F-35*01*2016-09-23
00815965021904LifeGlobal® MicropipetMPHL-35*01*MPHL-35*01*2016-09-23
00815965021911LifeGlobal® MicropipetMPHL-30*01*MPHL-30*01*2016-09-23
00815965021928LifeGlobal® MicropipetMPIC-35*01*MPIC-35*01*2016-09-23
00815965021935LifeGlobal® MicropipetMPIC-30*01*MPIC-30*01*2016-09-23
00815965021942LifeGlobal® MicropipetMPIC-30L*01*MPIC-30L*01*2016-09-23

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