HYALURONIDSE 2212-10

GUDID 00859268006305

InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

INVITROCARE, INCORPORATED

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Primary Device ID00859268006305
NIH Device Record Key5b283502-9a3f-434f-8179-3824e9ee73b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYALURONIDSE
Version Model Number2212-10
Catalog Number2212-10
Company DUNS190094230
Company NameINVITROCARE, INCORPORATED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859268006305 [Primary]

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 Date2022-08-08
Device Publish Date2022-07-29

Devices Manufactured by INVITROCARE, INCORPORATED

00859268006305 - HYALURONIDSE2022-08-08InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
00859268006305 - HYALURONIDSE2022-08-08 InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined so
00859268006275 - HTF HEPES2021-11-12 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been fo
00859268006282 - SPERM WASH MEDIUM2021-11-12 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
00859268006008 - HTF culture medium2018-07-06 HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF u
00859268006015 - HTF HEPES2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
00859268006022 - HTF HEPES2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
00859268006039 - SPERM WASH MEDIUM2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
00859268006053 - SPERM WASH MEDIUM2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
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