SpermSelect Mini Kit

GUDID 60888937003620

Contents: one SpermSelect System and one MiniSpace

Coopersurgical, Inc.

Spermatozoa/semen motility medium supplement
Primary Device ID60888937003620
NIH Device Record Keycce28003-7cc4-4084-b08d-d881533ac842
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpermSelect Mini Kit
Version Model NumberSM601-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
GS160888937003620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCurette, Suction, Endometrial (And Accessories)

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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