Cytology Brush CB-1315

GUDID 10816207020522

Flexible endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

Flexible endoscopic cytology brush, single-use

Primary Device ID	10816207020522
NIH Device Record Key	bf49c17a-8f8b-40cc-9719-adb9b963e01e
Commercial Distribution Discontinuation	2019-11-04
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Cytology Brush
Version Model Number	CB-1315
Catalog Number	CB-1315
Company DUNS	825239189
Company Name	ENDO-THERAPEUTICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com
Phone	844-400-3636
Email	customerservice@endotherapeutics.com

Device Dimensions

Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	1.7 Millimeter
Length	150 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207020525 [Primary]
GS1	10816207020522 [Package] Contains: 00816207020525 Package: box [10 Units] Discontinued: 2019-11-04 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K800966

FDA Product Code

FDX	Endoscopic Cytology Brush

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-11-05
Device Publish Date	2016-09-20

On-Brand Devices [Cytology Brush]

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