V-HYADASE

GUDID 04260650071836

V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).

VITROMED GmbH

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium
Primary Device ID04260650071836
NIH Device Record Keydbc42e4c-80c7-4498-b73a-15a0a6e14d33
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-HYADASE
Version Model NumberV-HYA
Company DUNS315234102
Company NameVITROMED GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260650070136 [Primary]
GS104260650071836 [Package]
Contains: 04260650070136
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-24
Device Publish Date2023-07-14

Devices Manufactured by VITROMED GmbH

04260650071034 - V-PVP2024-05-13 V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) mediu
04260650071836 - V-HYADASE 2023-07-24V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).
04260650071836 - V-HYADASE 2023-07-24 V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contain
04260650071805 - V-SPERM WASH2023-03-08 V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim
04260531792249 - V-CENTERWELL-602022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792270 - V-CULTUREDISH-602022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792294 - V-CULTUREDISH-902022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792317 - V-CULTUREDISH-352022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792393 - V-ICSIDISH-502022-12-01 IVF Labware are ready-to-use plastic disposables.

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