FDA.reportPublic FDA data

Nunc IVF Center Well Dish

Primary DI
00866630000403
Brand
Nunc IVF Center Well Dish
Company
Nalge Nunc International Corporation
Model
150260
Device description
IVF CENTER WELL DISH
Published
2018-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K090429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090429000NUNC IVF CENTERWELL AND ICSI DISHESThermo Fisher Scientific (Nalge Nunc Intl)2009-09-18MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866630000434PackageGS1120In Commercial Distribution
00866630000403PrimaryGS10
80866630000409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866630000434008666300004348666300004340866630000434
00866630000403008666300004038666300004030866630000403
8086663000040980866630000409

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA container intended exclusively 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 used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
080844844
Device count
3
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850016058390Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Racked3742202022-07-22
10850016058628Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded5000-10202022-07-26
10850016058581Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5000-00122022-06-11
10850016058611Nalgene™ System 100™ Cryogenic Tube, 1 mL externally-threaded5000-10122022-07-26
10850016058406Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Coded-rack374220-BR2022-07-22
10850016058468Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Coded-rack374222-BR2022-07-20
10850016058680Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5012-00122022-08-08
10850016058505Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D3742592022-07-25
10850016058499Nunc™ Cryobank™ Vial, 2 mL internally-threaded3742582022-07-20
10850016058437Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Coded-rack374221-BR2022-07-22
10850016058529Nunc™ Cryobank™ Vial, 5 mL internally-threaded3742612022-07-25
10850016058697Nalgene™ Cryogenic Tube, 2 mL externally-threaded5012-00202022-08-08
10850016058420Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Racked3742212022-07-22
10850016058482Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Coded-rack374223-BR2022-07-29
10850016058475Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Racked3742232022-07-20
10850016058451Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Racked3742222022-07-20
10850016058666Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded, Barcoded5001-10202022-08-08
10850016058598Nalgene™ Cryogenic Tube, 2 mL externally-threaded5000-00202022-06-11
10850016058659Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded5001-00502022-08-08
10850016058413Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Lock-rack374220LOCK2022-07-22

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Primary DI, Brand, Company table
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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
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06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
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