IVF ICSI Dish

GUDID H2861502655

NALGE NUNC INTERNATIONAL CORPORATION

Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish
Primary Device IDH2861502655
NIH Device Record Key2e48e4fa-5361-4642-a158-6093d8784a2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIVF ICSI Dish
Version Model NumberNA
Company DUNS194082517
Company NameNALGE NUNC INTERNATIONAL CORPORATION
Device Count120
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com
Phone(800) 625-4327
EmailRocReg@thermofisher.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 21 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH2861502651 [Unit of Use]
HIBCCH2861502655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQKLabware, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by NALGE NUNC INTERNATIONAL CORPORATION

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30850016060465 - Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box2022-09-12 90ML/48 SPCWLB,ORCAP,DSPNSR,ST
30850016060472 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap2022-09-12 90ML/53MM SPC W/LBL, WH CAP,ST
30850016060489 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap2022-09-12 90ML/53MM SPCW/LBL, NTL CAP,ST
30850016060496 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap2022-09-12 90ML/53MM SPC W/LBL, OR CP, ST
30850016060502 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap2022-09-12 60ML/48MMSPCW/LBL, OR CAP, ST
30850016060519 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap2022-09-12 60ML/48MMSPCW/LBL, WH CAP, ST
30850016060526 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap2022-09-12 60ML/48MMSPCW/LBL, GRN CAP, ST
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