Cytology Brush CB-1615

GUDID 10816207020539

Flexible endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

Flexible endoscopic cytology brush, single-use
Primary Device ID10816207020539
NIH Device Record Key00621c57-bc31-4502-8561-2985877bb020
Commercial Distribution Discontinuation2019-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCytology Brush
Version Model NumberCB-1615
Catalog NumberCB-1615
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

Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.4 Millimeter
Length150 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
GS100816207020532 [Primary]
GS110816207020539 [Package]
Contains: 00816207020532
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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