SpermSelect Curve Kit

GUDID 60888937003644

Contents: One SpermSelect System and one TheCurve

Coopersurgical, Inc.

Spermatozoa/semen motility medium supplement
Primary Device ID60888937003644
NIH Device Record Keya75db9e2-e6ce-480b-bd6a-29d78ba48b79
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpermSelect Curve Kit
Version Model NumberSM603-F
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160888937003644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MFDCannula, Intrauterine Insemination

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 Date2016-08-09

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