Collection Dish 90 mm - Hertart ApS

Duns Number:305164017

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More Product Details

Catalog Number

-

Brand Name

Collection Dish 90 mm

Version/Model Number

16007

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUD

Product Code Name

Labware, Assisted Reproduction, Exempt

Device Record Status

Public Device Record Key

6b5d667b-4e61-421d-b883-9d850e8914fe

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

May 29, 2020

Additional Identifiers

Package DI Number

27350025914545

Quantity per Package

24

Contains DI Package

17350025914548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HERTART APS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3