V-ICSIPET INJECTION - V-ICSIPET is a borosilicate glass micropipette - VITROMED GmbH

Duns Number:342250668

Device Description: V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipet V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike).

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More Product Details

Catalog Number

V-INJ-S3-25

Brand Name

V-ICSIPET INJECTION

Version/Model Number

V-ICSIPET Injection with Spike 25

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

PUC

Product Code Name

Microtools, Assisted Reproduction (Pipettes), Exempt

Device Record Status

Public Device Record Key

b5dc72fe-384d-4473-8557-4b7848254302

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