SPERMCARE 100% - Gradient System 2220-100

GUDID 00859268006176

SPERMCARE 100% - Gradient System is a 100% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE 100% - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

INVITROCARE, INCORPORATED

IVF medium
Primary Device ID00859268006176
NIH Device Record Keye7ddcae8-13f5-49d7-a821-d48fb771836b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPERMCARE 100% - Gradient System
Version Model Number2220-100
Catalog Number2220-100
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
GS100859268006176 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by INVITROCARE, INCORPORATED

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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