6.5" Cytology Brush

GUDID 50813360023023

TEAM TECHNOLOGIES, INC.

Cervical cytology scraper, single-use
Primary Device ID50813360023023
NIH Device Record Key9eae2246-b9d1-41e3-a3f0-65edd1559c22
Commercial Distribution StatusIn Commercial Distribution
Brand Name6.5" Cytology Brush
Version Model Number1
Company DUNS078550672
Company NameTEAM TECHNOLOGIES, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813360023028 [Primary]
GS110813360023025 [Package]
Contains: 00813360023028
Package: Bag [100 Units]
In Commercial Distribution
GS120813360023022 [Package]
Contains: 10813360023025
Package: Inner [1000 Units]
In Commercial Distribution
GS130813360023029 [Package]
Contains: 10813360023025
Package: Case [3000 Units]
In Commercial Distribution
GS140813360023026 [Package]
Contains: 20813360023022
Package: Case [6000 Units]
In Commercial Distribution
GS150813360023023 [Package]
Contains: 00813360023028
Package: Case [3000 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2016-08-16

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