Cytology Brush CB-1311

GUDID 10816207020515

Flexible endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

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Primary Device ID10816207020515
NIH Device Record Keyb7104839-fa57-4390-8181-ed908558c13c
Commercial Distribution Discontinuation2019-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCytology Brush
Version Model NumberCB-1311
Catalog NumberCB-1311
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

Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter1.7 Millimeter
Length110 Centimeter

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
GS100816207020518 [Primary]
GS110816207020515 [Package]
Contains: 00816207020518
Package: box [10 Units]
Discontinued: 2019-11-04
Not 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 Number3
Public Version Date2019-11-05
Device Publish Date2016-09-20

On-Brand Devices [Cytology Brush]

10816207020546Flexible endoscopic cytology brush
10816207020539Flexible endoscopic cytology brush
10816207020522Flexible endoscopic cytology brush
10816207020515Flexible endoscopic cytology brush
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