EndoTBrush Cytology Brush ET1422

GUDID 10816207020157

Endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

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Primary Device ID10816207020157
NIH Device Record Keyc6990898-23ee-42c5-8cd2-d8b5375a1336
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTBrush Cytology Brush
Version Model NumberET1422
Catalog NumberET1422
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 Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length150 Centimeter
Outer Diameter2.4 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
GS100816207020150 [Primary]
GS110816207020157 [Package]
Contains: 00816207020150
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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