FDA.reportPublic FDA data

IVF Center Well Dish

Primary DI
H2861502605
Brand
IVF Center Well Dish
Company
NALGE NUNC INTERNATIONAL CORPORATION
Model
NA
Catalog number
150260
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
H2861502605PrimaryHIBCC0
H2861502601Unit of UseHIBCC0

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
Storage Environment Temperature21 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-625-4327rocreg@thermofisher.com

Regulatory Flags#

DUNS number
194082517
Device count
120
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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