FDA.reportPublic FDA data

Micro well group culture dish, 16-well

Primary DI
17350025919062
Brand
Micro well group culture dish, 16-well
Company
Hertart ApS
Model
16606
Published
2016-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
K150756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150756000Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart2015-07-20MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025919062PrimaryGS10
07350025919065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591906217350025919062
07350025919065073500259190657350025919065

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305164017
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350025919048Micro well group culture dish, 9-well166042016-06-15
17350025914562Sperm Collection Container161022021-04-30
17350025914616Pasteur Pipette 1 mL162012020-12-22
17350025914623Pasteur Pipette 3 mL162022020-12-22
07350025914541Collection Dish 90 mm160072020-05-29
07350025914558Oocyte Collection Tube 14 mL161012020-05-29
27350025914590Centrifuge Tube 15 mL161052020-05-29
27350025914606Centrifuge Tube 50 mL161062020-05-29

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00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
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