EndoTBrush Cytology Brush ET1421

GUDID 10816207020140

Endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

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Primary Device ID10816207020140
NIH Device Record Keycd03e4f3-b9c1-467d-812a-1a646c775cdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTBrush Cytology Brush
Version Model NumberET1421
Catalog NumberET1421
Company DUNS825239189
Company NameENDO-THERAPEUTICS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com

Device Dimensions

Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter1.7 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100816207020143 [Primary]
GS110816207020140 [Package]
Contains: 00816207020143
Package: box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDXEndoscopic Cytology Brush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

On-Brand Devices [EndoTBrush Cytology Brush]

10816207020164Endoscopic cytology brush
10816207020157Endoscopic cytology brush
10816207020140Endoscopic cytology brush
10816207020133Endoscopic cytology brush
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