Sepa Sperm Wash Solution 92149

GUDID 04573316381317

Sepa Sperm Wash Solution with Gentamicin, 100mL

KITAZATO CORPORATION

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 ID04573316381317
NIH Device Record Key72b0d0ab-150c-4b0b-b042-1e0e546c0797
Commercial Distribution StatusIn Commercial Distribution
Brand NameSepa Sperm Wash Solution
Version Model NumberSepa Sperm Wash Solution
Catalog Number92149
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
GS104573316381317 [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

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