V-DENUPET - The tip of V-DENUPET is available in a range of - VITROMED GmbH

Duns Number:342250668

Device Description: The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µ The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.

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More Product Details

Catalog Number

V-DEN-135

Brand Name

V-DENUPET

Version/Model Number

V-DENUPET 135

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

K192146,K192146

Product Code Details

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Device Record Status

Public Device Record Key

54747e93-d48e-4c3f-8cc7-c1fc99c1074e

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITROMED GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42