Medscand Sample Collection Kit

GUDID 20888937022388

Medscand Sample Collection Kit

Coopersurgical, Inc.

Urogenital specimen collection kit IVD, clinical
Primary Device ID20888937022388
NIH Device Record Key63733b55-b2a6-480d-9dc9-50e21bdf4a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedscand Sample Collection Kit
Version Model Number70124-001
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937022384 [Primary]
GS120888937022388 [Package]
Contains: 00888937022384
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHTSpatula, Cervical, Cytological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

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60888937027206 - ERPeak2024-04-18 IVD Sample kit
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00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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