BD Surepath Sample Collection Kit

GUDID 60888937021402

Cervical cytology sampling kit

Coopersurgical, Inc.

Papanicolaou smear kit
Primary Device ID60888937021402
NIH Device Record Keyc398ea31-0430-40b7-b907-224448b223d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Surepath Sample Collection Kit
Version Model Number490525
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
GS120888937021404 [Primary]
GS160888937021402 [Package]
Contains: 20888937021404
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHTSpatula, Cervical, Cytological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

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