Sepa Sperm Solution 92148

GUDID 04573316381300

100% SepaSperm solution with Gentamicin, 100mL

KITAZATO CORPORATION

IVF medium
Primary Device ID04573316381300
NIH Device Record Keya4fe131c-915a-448e-b19e-5adf99bda29c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSepa Sperm Solution
Version Model NumberSepa Sperm Solution
Catalog Number92148
Company DUNS711091157
Company NameKITAZATO CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104573316381300 [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 Number2
Public Version Date2023-05-31
Device Publish Date2023-01-13

Devices Manufactured by KITAZATO CORPORATION

14573316385480 - BS(Basic Solution) Pack 4 vials2024-10-25 BS(Basic Solution) Pack of 4x1.5ml vials
14573316385497 - ES(Equilibration Solution) Pack 4 vials2024-10-25 ES(Equilibration Solution) Pack 4x1.5ml vials
14573316385503 - VS(Vitrification Solution) Pack 4 vials2024-10-25 VS(Vitrification Solution) Pack of 4x1.5ml vials
14573316385510 - BS(Basic Solution) Pack 4 vials 4ml2024-10-25 BS(Basic Solution) Pack of 4x4ml vials
14573316385527 - ES(Equilibration Solution) Pack 4 vials 4ml2024-10-25 ES(Equilibration Solution) Pack 4x4ml vials
14573316385534 - VS(Vitrification Solution) Pack 4 vials 4ml2024-10-25 VS(Vitrification Solution) Pack of 4x4ml vials
14573316385558 - DS(Diluent Solution) Pack 4 vials2024-10-25 DS(Diluent Solution) Pack of 4x4ml vials
14573316385565 - WS(Washing Solution) Pack 4 vials2024-10-25 WS(Washing Solution) Pack of 4x4ml vials

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